International Journal of Chemistry and Pharmaceutical Sciences
Evaluation of Nootropic Activity of Selected Plant Extract in Mouse Model
The present study evaluated the nootropic activity of methanolic extract of Vigna angularis (adzuki bean) in scopolamine-induced amnesia in Swiss albino mice. Phytochemical screening revealed the presence of alkaloids, flavonoids, phenols, tannins, saponins, terpenoids, steroids, and glycosides, compounds known for their neuroprotective and antioxidant roles. Acute oral toxicity studies conducted as per OECD 423 guidelines confirmed that the extract was safe up to 2000 mg/kg (LD₅₀ cut-off > 2000 mg/kg), enabling the selection of test doses (50, 100, 200 mg/kg) for pharmacological evaluation. In behavioral studies, scopolamine caused memory impairment as evidenced by prolonged transfer latency in the Elevated Plus Maze, reduced spontaneous alternation in the Y-Maze, and impaired learning and retention in the Morris Water Maze. Administration of Vigna angularis extract significantly improved these deficits in a dose-dependent manner, with medium and high doses showing effects comparable to Piracetam (100 mg/kg). Biochemical analysis supported the behavioral findings. Scopolamine increased acetylcholinesterase (AChE) activity, malondialdehyde (MDA), and nitric oxide (NO) levels, while decreasing antioxidant enzymes (SOD, CAT, GPx). Treatment with Vigna angularis extract reduced AChE activity and oxidative stress markers while enhancing antioxidant enzyme activities, restoring redox balance and cholinergic function. Histopathological examination of the hippocampus revealed that scopolamine induced neuronal degeneration, cell loss, and vacuolization. Extract-treated groups demonstrated marked neuroprotection, with high-dose Vigna angularis showing neuronal integrity comparable to Piracetam and normal controls.
Copyright (c) 2026 Author https://creativecommons.org/licenses/by-nc/4.0
Estimation of Combined Effect of ‘N –Acetylcysteine’ and ‘Vitamin C’ on Cyclophosphamide Induced Immunosuppressed Mice Model
The present study was designed to evaluate the protective and restorative potential of N-acetylcysteine (NAC) and Vitamin C, both individually and in combination, against cyclophosphamide (CYP)-induced immunosuppression in Swiss albino mice. Cyclophosphamide, a commonly used chemotherapeutic agent, is associated with immunotoxic side effects such as leukopenia, oxidative stress, and suppression of humoral and cellular immune functions. The study was conducted using five experimental groups: normal control, cyclophosphamide control, NAC-treated, Vitamin C–treated, and a combination group. Immunosuppression was successfully induced with cyclophosphamide at 150 mg/kg i.p., which resulted in ~58% reduction in WBC count, significant weight loss, increased lipid peroxidation, depletion of antioxidant enzymes (GSH, SOD, catalase), and histopathological damage to spleen, thymus, and bone marrow. Treatment with NAC and Vitamin C individually led to partial improvement in hematological and biochemical parameters, including significant increases in WBC counts, hemoglobin levels, antioxidant enzyme activity, and immune responses such as antibody titer and delayed-type hypersensitivity (DTH). Importantly, the combination therapy restored hematological, biochemical, immunological, and histological parameters close to normal levels, demonstrating a synergistic protective effect.
In-Vitro and In-Vivo Evaluation of the Antidiabetic Potential and Antioxidant Properties of Selected GS Extract in DIO Mice Model
Diabetes mellitus (DM) is a persistent metabolic disorder marked by elevated blood glucose levels (hyperglycemia), arising from impaired insulin secretion, defective insulin action, or a combination of both. It is one of the most prevalent non-communicable diseases globally and is considered a major public health challenge of the 21st century. This study was undertaken to evaluate the antidiabetic and antioxidant potential of the methanolic extract of Gymnema sylvestre through both in-vitro and in-vivo approaches, with particular emphasis on the DIO mouse model. The findings clearly demonstrate that the extract exhibits significant hypoglycemic, hypolipidemic, and antioxidant activities, thereby supporting its ethnopharmacological relevance in the management of diabetes mellitus. Overall, the Gymnema sylvestre extract appears to work through multiple pathways it slows sugar absorption, enhances antioxidant defenses, and protects key organs. Its effectiveness was comparable to the diabetes drug metformin, making it a promising natural option for managing diabetes.
Development and Validation of a Robust Stability-Indicating RP-HPLC Method for Quantitative Analysis of Tepotinib in Pharmaceutical Formulations
A highly accurate and reliable Reverse Phase -High Performance Liquid Chromatography technique was designed and validated for the quantitative analysis of Tepotinib in drug products. Separation was achieved on a Luna® C18 column (3 μm, 150 mm × 5 mm I.D.) using an isocratic mobile phase consisting of 80% phosphate buffer (0.01 N K₂HPO₄, adjusted to pH 3.5) and 20% acetonitrile at a flow rate of 1.0 mL/min. Detection took place at 270 nm, and Tepotinib was observed at a retention time of 2.235 mins. The method met ICH validation standards, demonstrating selectivity, excellent linearity over the range of 10–50 µg/mL (correlation coefficient R² > 0.999), and accuracy (recovery between 99.26–101.7%). Precision was confirmed, with intra-day and inter-day relative standard deviations of 0.92% and 0.86%, respectively. Test recovery underscored the method’s accuracy, and deliberate adjustments to parameters like temperature, flow, and mobile phase composition established its robustness. This protocol is well-suited for quality control and stability testing of Tepotinib formulations.
Next-Generation Pharmaceutical Analysis Using Artificial Intelligence and Machine Learning Approaches
Artificial Intelligence (AI) and Machine Learning (ML) are rapidly advancing pharmaceutical analysis by improving analytical accuracy, speed, automation, and data interpretation. Conventional pharmaceutical analytical methods often involve complex procedures, extensive manual calculations, and time-consuming experimental work. The integration of AI with chromatographic, spectroscopic, and chemometric techniques has significantly improved analytical efficiency and decision-making in pharmaceutical research and quality control laboratories.AI and ML applications are increasingly utilized in High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), spectroscopy, dissolution testing, impurity profiling, stability studies, and Process Analytical Technology (PAT). Machine learning algorithms such as artificial neural networks, support vector machines, and deep learning models assist in pattern recognition, spectral interpretation, predictive modeling, and method optimization. These technologies help reduce human error, improve reproducibility, and enhance analytical robustness.AI-driven analytical systems also support regulatory compliance, data integrity, and real-time monitoring in pharmaceutical manufacturing. Despite their advantages, challenges related to data quality, model validation, cyber security, and regulatory acceptance remain important concerns. However, continuous advancements in AI, cloud computing, and big data analytics are expected to transform pharmaceutical analytical laboratories into intelligent and automated systems. This review highlights the major applications, benefits, challenges, and future perspectives of AI and ML in next-generation pharmaceutical analysis.
Synthesis and Characterization of Plant Derived Silver Nanoparticles Using UV-VIS Spectroscopy
The present study focuses on the green synthesis, characterization, and evaluation of silver nanoparticles (AgNPs) using plant extracts of Azadirachta indica (Neem) leaves and Acorus calamus rhizomes. Green nanotechnology offers an eco-friendly, cost-effective, and sustainable alternative to conventional physical and chemical nanoparticle synthesis methods, which often involve toxic chemicals and high energy consumption. In this study, aqueous extracts of both plants were prepared and utilized as reducing and stabilizing agents for the synthesis of silver nanoparticles from silver nitrate solution. The formation of nanoparticles was initially indicated by a visible color change from pale yellow to brown, confirming the reduction of Ag ions to Ag. The synthesized nanoparticles were characterized using UV-Visible spectroscopy, which revealed distinct Surface Plasmon Resonance (SPR) peaks at approximately 421 nm for Azadirachta indica and 384 nm for Acorus calamus, confirming successful nanoparticle formation. Comparative analysis demonstrated that Azadirachta indica exhibited superior reducing ability, faster synthesis rate, and greater stability of nanoparticles compared to Acorus calamus. More than 90% reduction of silver ions occurred within 4 hours, indicating rapid nanoparticle formation. The enhanced efficiency of neem extract is attributed to the presence of phytochemicals such as flavonoids, phenolics, and terpenoids, which play a crucial role in reduction and stabilization processes. The study concludes that plant-mediated synthesis of silver nanoparticles is an effective and environmentally benign approach with significant potential for antimicrobial and biomedical applications. The findings highlight the importance of phytoconstituents in nanoparticle synthesis and suggest further exploration for large-scale production and therapeutic applications.
New Spectrophotometric Assay for the Determination of Selected Drugs In Pure and Dosage Forms
The present study focuses on the development and validation of simple, sensitive, accurate, and reproducible analytical methods for the quantitative determination of Meropenem in bulk drug and pharmaceutical dosage forms. Visible spectrophotometric methods were developed based on various chromogenic reactions involving reagents such as DDQ, p-chloranilic acid, 4-aminophenazone, isoniazid, anthranilic acid, 2-chlorophenyl hydrazine, 2,4-dinitrophenylhydrazine, bromothymol blue, bromocresol purple, and MBTH in the presence of Fe(III). These reagents form stable colored complexes with Meropenem, which were measured at their respective absorption maxima. Optimization of experimental conditions including reagent concentration, pH, temperature, reaction time, and solvent system was carried out to achieve maximum color intensity and stability. The developed methods obeyed Beer–Lambert’s law within specific concentration ranges, demonstrating good linearity with high correlation coefficients. Analytical parameters such as accuracy, precision, sensitivity, and reproducibility were evaluated in accordance with standard validation guidelines. The proposed methods were successfully applied to the analysis of Meropenem in pharmaceutical formulations, and the results were found to be in good agreement with reference methods. Due to their simplicity, cost-effectiveness, and reliability, the developed spectrophotometric methods are suitable for routine quality control analysis of Meropenem in pharmaceutical industries.
QBD-Driven RP-HPLC Method Development and Validation for Ipragliflozin and Saxagliptin in Pharmaceutical Dosage Forms Following ICH Guidelines
A robust and validated Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed for the simultaneous estimation of Ipragliflozin and Saxagliptin in pharmaceutical dosage forms. Method optimization was achieved using a Box-Behnken Design, evaluating the influence of key chromatographic parameters such as buffer pH and flow rate. Optimal separation was accomplished using an Inspire C18-EP column (4.6 × 250 mm, 5 µm) with a mobile phase of methanol and phosphate buffer (pH 6.0) in a 70:30 ratio, at a flow rate of 1 mL/min and UV detection at 254 nm. The method demonstrated excellent resolution (3.52), acceptable tailing factors (<1.2), and high theoretical plate counts, confirming efficient peak performance. ANOVA results validated the statistical significance of the model, and all system suitability parameters met regulatory standards. The method was thoroughly validated in accordance with ICH guidelines, showing excellent linearity for Ipragliflozin (30–150 µg/mL, R² = 0.9993) and Saxagliptin (3–15 µg/mL, R² = 0.9994). Assay results confirmed high accuracy with recoveries of 99.7% and 99.6% respectively. Precision studies yielded %RSD values below 2%, indicating strong repeatability and intermediate precision. Sensitivity was established through low LOD and LOQ values, while robustness was confirmed under deliberate variations in chromatographic conditions. Overall, the developed RP-HPLC method is simple, precise, accurate, and reliable, making it highly suitable for routine quality control of Ipragliflozin and Saxagliptin in bulk and formulated pharmaceutical products.
Copyright (c) 2026 Authors https://creativecommons.org/licenses/by-nc/4.0
QbD-Guided RP-HPLC Method Development and Validation for Bisoprolol and Perindopril in Pure and Formulated Dosage Forms
A robust and optimized Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed for the simultaneous estimation of Perindopril and Bisoprolol in pharmaceutical dosage forms. Method optimization was performed using a Box-Behnken response surface design, with statistical analysis via ANOVA confirming the significance of resolution and tailing factor models (p < 0.05). Flow rate emerged as a critical factor influencing both responses. Diagnostic plots—including normal residuals, predicted vs. actual values, and 3D surface plots—validated the model's accuracy and predictive capability. System suitability parameters such as resolution (>5), tailing factor (<2), and theoretical plate count (>2000) met all acceptance criteria, ensuring reliable chromatographic performance. The method was validated according to ICH guidelines, demonstrating excellent linearity for Perindopril and Bisoprolol with correlation coefficients (R²) exceeding 0.999. Precision studies showed %RSD values below 2%, confirming repeatability and intermediate precision. Accuracy was supported by recovery rates within 98–102% across multiple concentration levels. Sensitivity was established with low LOD and LOQ values for both analytes, and robustness was confirmed under deliberate variations in chromatographic conditions. Overall, the developed RP-HPLC method is simple, precise, accurate, and robust, making it highly suitable for routine quality control of Perindopril and Bisoprolol in bulk and formulated products.
Reverse Phase High-Performance Liquid Chromatography (RP-HPLC)
Synthesis, Characterization and Biological Activity of some 2,4,6 tri substituted Pyrimidine Derivatives
A series of novel compounds were synthesized and characterized using appropriate spectroscopic techniques. All synthesized compounds were evaluated for their antibacterial activity against various bacterial pathogens using standard in vitro assays. The results of antibacterial screening revealed that all titled compounds exhibited significant activity against the tested bacterial strains. Notably, compounds SB-4, SB-5, SB-8, and SB-9 demonstrated pronounced antibacterial potency that was comparable to or exceeded that of standard reference antibiotics, suggesting superior therapeutic potential. Structure-activity relationship analysis indicated that the enhanced antibacterial efficacy of these lead compounds could be attributed to the presence of electron-donating groups, particularly the nitro group positioned at the 6th position of the parent molecular scaffold. The electron-donating characteristics of the nitro moiety appeared to favorably influence the compound's interaction with bacterial targets, resulting in improved antimicrobial efficacy. To further elucidate the structural features responsible for the observed biological activity and to optimize the lead compounds, subsequent investigations will involve quantitative structure-activity relationship (QSAR) modeling and molecular docking studies. These computational approaches will provide valuable insights into the binding mechanisms and physicochemical properties that correlate with antibacterial activity, thereby facilitating the rational design and development of more potent antibacterial agents from this chemical series.
Synthesis, Characterization and Anthelmentic Activity of Pyridazine Derivative
A series of novel pyridazinone and pyridazine chloride derivatives were synthesized and characterized using spectroscopic techniques including infrared (IR) and nuclear magnetic resonance (NMR) spectroscopy. All synthesized compounds displayed characteristic peaks consistent with their proposed structures. The compounds were subsequently evaluated for anthelmintic activity using standardized in vitro methods. The results demonstrated that all title compounds exhibited significant anthelmintic activity, with compounds C2 and C6, bearing electron-rich chloro substituents at the 4th position of the pyridazinone and pyridazine chloride nuclei, showing relatively marked anthelmintic potency compared to other analogues. Structure-activity relationship analysis indicated that electron-donating groups, particularly chloro groups, enhanced the anthelmintic efficacy of these compounds. These findings underscore the potential for further structural optimization through the introduction of diverse electron-withdrawing and electron-donating substituents at the 4th position of the pyridazinone and pyridazine chloride scaffolds. The present work suggests that rational molecular design incorporating such substituents may yield significantly more potent anthelmintic and antioxidant agents with improved therapeutic profiles. Future investigations should focus on synthesizing additional analogues with varied electronic properties to identify lead compounds for preclinical and clinical development.
RP-HPLC Stability Indicating Method Development and Validation for Simultaneously Estimation of Telmisartan and Azelnidipine in Its Bulk and Pharmaceutical Dosage Form
A simple, precise, accurate and new method was established for simultaneous estimation of Azelnidipine and Telmisartan by RP-HPLC methods. The chromatographic conditions were successfully developed for the separation of Azelnidipine and Telmisartan by using Inertsil ODS C18 column (4.6×250mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) ACN : KH2PO4 PH3, detection wavelength was 225nm. The instrument used for HPLC , WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.798mins and 3.587mins. The % purity of Azelnidipine and Telmisartan was found to be 99.87% and 100.27% respectively. The system suitability parameters for Azelnidipine and Telmisartan such as theoretical plates and tailing factor were found to be 4260, 1.2 and 5085 and 1.2, the resolution was found to be 7.67. The precision study was precision, robustness and repeatabilty. LOD value was 3.72 and 0.0242 and LOQ value was 7.40 and 0.0202 respectively. Hence the suggested RP-HPLC can be used for routine analysis of Azelnidipine and Telmisartan in API and Pharmaceutical dosage form.
Copyright (c) 2025 Author https://creativecommons.org/licenses/by-nc/4.0
Implementation of QBD Approach to the Analytical Method Development and Validation for the Simultaneous Estimation of Teneligliptin and Pioglitazone in Pharmaceutical Dosage Form
A simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Teneligliptin and Pioglitazone in bulk and combined pharmaceutical dosage forms, in accordance with ICH Q2(R1) guidelines. Chromatographic separation was achieved using a YMC pack pro-C18 column (4.6 ×150 mm, 5μm) with a mobile phase comprising 66% methanol and 44% phosphate buffer (pH 4.0) at a flow rate of 1.0 mL/min. Detection was performed at 229 nm with an injection volume of 10μL and a run time of 10 minutes. The method demonstrated excellent linearity over the concentration ranges of 20–100μg/mL for Teneligliptin and 15–75μg/mL for Pioglitazone, with correlation coefficients of 0.9998 and 0.9993, respectively. Precision studies yielded %RSD values below 0.5%, while recovery results (98.0–100.6%) confirmed the method’s accuracy. The limits of detection and quantification were found to be 0.05μg/mL, 0.17μg/mL for Teneligliptin, and 0.05μg/mL and 0.16μg/mL for Pioglitazone, respectively. Robustness testing confirmed the method’s reliability under small deliberate variations in chromatographic conditions. The validated method is specific, sensitive, and suitable for routine quality control analysis of Teneligliptin and Pioglitazone in pharmaceutical formulations.
Antidiabetic Fixed-Dose Formulation Analysis
Phosphate Buffer–Methanol Mobile Phase System
Low-Level Quantification of DPP-4 Inhibitor and TZD
QBD Approach to HPLC Method Development and Validation for the Simultaneous Estimation of Sulbactum and Durlobactum in Pharmaceutical Dosage Form
A simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Teneligliptin and Pioglitazone in bulk and combined pharmaceutical dosage forms, in accordance with ICH Q2(R1) guidelines. Chromatographic separation was achieved using a YMC pack pro-C18 column (4.6 ×150 mm, 5μm) with a mobile phase comprising 66% methanol and 44% phosphate buffer (pH 4.0) at a flow rate of 1.0 mL/min. Detection was performed at 229 nm with an injection volume of 10μL and a run time of 10 minutes. The method demonstrated excellent linearity over the concentration ranges of 20–100μg/mL for Teneligliptin and 15–75μg/mL for Pioglitazone, with correlation coefficients of 0.9998 and 0.9993, respectively. Precision studies yielded %RSD values below 0.5%, while recovery results (98.0–100.6%) confirmed the method’s accuracy. The limits of detection and quantification were found to be 0.05μg/mL, 0.17μg/mL for Teneligliptin, and 0.05μg/mL and 0.16 μg/mL for Pioglitazone, respectively. Robustness testing confirmed the method’s reliability under small deliberate variations in chromatographic conditions. The validated method is specific, sensitive, and suitable for routine quality control analysis of Teneligliptin and Pioglitazone in pharmaceutical formulations.
Formulation Evaluation and Optimization of fast Dissolving Tablet of Flurbiprofen
This study focused on developing patient-friendly mouth-disintegrating tablets (MDTs) of Flurbiprofen using a simple and scalable direct compression technique. A UV-Visible spectrophotometric method was optimized for quantifying Flurbiprofen, identifying a maximum absorbance at 257 nm in 0.1N HCl, ensuring reliable analysis of the drug in tablet formulations. MDTs were formulated using commonly utilized superdisintegrants such as sodium starch glycolate (SSG), crospovidone, and croscarmellose sodium. Comprehensive evaluation of key tablet properties including hardness, friability, weight variation, and drug content revealed results consistently within acceptable pharmacopeial limits across all formulations. In vitro dissolution studies highlighted rapid drug release for all batches, with the crospovidone-containing formulation (F-6) exhibiting the most superior performance by releasing approximately 99% of the drug within 30 minutes. Comparative assessments demonstrated that crospovidone provided a faster release profile relative to other superdisintegrants. The successful preparation of Flurbiprofen MDTs with minimal excipients and a straightforward manufacturing process meets the objective of creating an efficient, easy-to-administer dosage form supported by a practical analytical method for quality assurance.
Development and Validation of analytical method for simultaneous estimation of Econazole and Triamcinolone by RP- HPLC
А Rаpіd аnd Pгеcіsе Rеvегsе Phаsе Hіgh Pегfoгmаncе Lіquіd Chгomаtogгаphіc mеthod hаs bееn dеvеlopеd foг thе vаlіdаtеd of Econozole & Triamcinolone, іn іts puге foгm аs wеll аs іn tаblеt dosаgе foгm. Chгomаtogгаphy wаs cаггіеd out on X-Tегга C18 (4.6x150mm, 5µm) column usіng а mіxtuге of Mеthаnol: TЕА Buffег pH 4.5: Аcеtonіtгіlе (65:15:20) аs thе mobіlе phаsе аt а flow гаtе of 1.0ml/mіn, thе dеtеctіon wаs cаггіеd out аt 212 nm. Thе геtеntіon tіmе of thе Econozole аnd Triamcinolone wаs 2.090, 5.289 ±0.02mіn геspеctіvеly. Thе mеthod pгoducе lіnеаг геsponsеs іn thе concеntгаtіon гаngе of 5-25mg/ml of Econozole аnd 45-225mg/ml of Triamcinolone. Thе mеthod pгеcіsіon foг thе dеtегmіnаtіon of аssаy wаs bеlow 2.0%RSD. Thе mеthod іs usеful іn thе quаlіty contгol of bulk аnd phагmаcеutіcаl foгmulаtіons.
Validated Method for the Simultaneous Estimation of Bempedoic Acid and Ezetimibe in Bulk and Tablet Formulation by RP-HPLC Method
A rapіɗ anɗ prеcіsе rеvеrsе phasе hіgh pеrfоrmancе lіquіɗ chrоmatоgraphіc mеthоɗ has bееn ɗеvеlоpеɗ fоr thе valіɗatеɗ оf Bempedoic Acid and Ezetimibe, іn іts purе fоrm as wеll as іn tablеt ɗоsagе fоrm. Chrоmatоgraphy was carrіеɗ оut оn a Phеnоmеnеx Gеmіnі C18 (4.6 x 150mm, 5µm) cоlumn usіng a mіxturе оf Mеthanоl: Watеr (25:75% v/v) as thе mоbіlе phasе at a flоw ratе оf 1.0ml/mіn, thе ɗеtеctіоn was carrіеɗ оut at 240 nm. Thе rеtеntіоn tіmе оf thе Bempedoic Acid and Ezetimibe was 2.256, 5.427 ±0.02mіn rеspеctіvеly. Thе mеthоɗ prоɗucе lіnеar rеspоnsеs іn thе cоncеntratіоn rangе оf 5-25mg/ml оf Bempedoic Acid and 25-125mg/ml оf Ezetimibe. Thе mеthоɗ prеcіsіоn fоr thе ɗеtеrmіnatіоn оf assay was bеlоw 2.0%RSƊ. Thе mеthоd іs usеful іn thе qualіty cоntrоl оf bulk and pharmacеutіcal fоrmulatіоns.
Stimulatneous Estimation of Ledipasvir and Sofosbuvir by RP–HPLC Method Devlopment and Validation
The optimization of chromatographic conditions for the analysis of Ledipasvir and Sofosbuvir was successfully achieved using a Platisil C18 Column (150×4.6mm, 3µm) at a flow rate of 1.0 ml/min, ensuring excellent peak shape and resolution. System suitability tests confirmed compliance with essential parameters, including resolution, tailing factor, and theoretical plate count, ensuring reliability. The retention times (RT) were recorded as 2.919 min for Ledipasvir and 3.934 min for Sofosbuvir, demonstrating distinct peak separation. Linearity studies indicated strong correlation coefficients (>0.999), enabling accurate quantification. Precision assessments revealed low %RSD values, confirming reproducibility, while accuracy tests showed recovery rates within 98-102%, validating method reliability. Robustness and ruggedness were evaluated by modifying chromatographic conditions such as flow rate and mobile phase composition. Despite slight variations, the method remained stable, maintaining consistent retention times and peak separation. Intermediate precision studies further supported assay consistency across different systems and days. The limits of detection (LOD) and limits of quantification (LOQ) were determined as 0.01 µg/ml for Ledipasvir and 0.02µg/ml for Sofosbuvir, highlighting the method’s sensitivity for trace analysis. In conclusion, the developed chromatographic method for Ledipasvir and Sofosbuvir is precise, accurate, linear, sensitive, and robust, making it suitable for routine pharmaceutical analysis and quality control. The validation results confirm compliance with regulatory standards, ensuring reliable identification and quantification of these antiviral drugs. Given its high stability and reproducibility, this method provides an efficient and dependable approach for analyzing Ledipasvir and Sofosbuvir in pharmaceutical formulations.
Quality by Design Assisted Chromatographic Method Development and Validation for Estimating Abrocitinib in Bulk and Dosage Forms by RP-HPLC Technique
A new method was established for simultaneous estimation of Tinidazole and Diloxanide furoate by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tinidazole and Diloxanide furoate by using Thermosil RP C18 (4.5×100 mm) 5.0µm, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol. The retention times were found to be 2.408mins and 3.016mins. The % purity of Tinidazole and Diloxanide furoate was found to be 99.24% and 101.27% respectively. The system suitability parameters for Tinidazole and Diloxanide furoate such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Tinidazole and Diloxanide furoate was found in concentration range of 50ppm-250ppm and 5ppm-25ppm and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.56% and 101.47%, %RSD for repeatability was 0.1 and 0.3, % RSD for intermediate precision was 0.19 and 0.57respectively. The precision study was precise, robust, and repeatable. LOD value was 4.27 and 6.80, and LOQ value was 0.0272 and 0.3125 respectively.
Method Development and Validation for Rapid Simultaneous Estimation of Tinidazole and Diloxanide Furoate in Pharmaceutical Dosage Form by Using RP-HPLC
Development and Validation of Stability Indicating Method for Simultaneous Estimation of Famotidine and Domperidone in Bulk and Tablet Dosage Forms Using RP-HPLC
A novel, precise, and accurate Reverse Phase-High Performance Liquid Chromatography (RP- HPLC) method was developed and validated for the simultaneous estimation of Famotidine (FAM) and Domperidone (DOM) in bulk and tablet dosage forms. The method was optimized using a Symmetry C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of 0.002 M Sodium dihydrogen phosphate buffer (pH 5.8) and acetonitrile (60:40, v/v) at a flow rate of 1 mL/min. Detection was performed at 287 nm using a Photo Diode Array (PDA) detector. The retention times for FAM and DOM were 3.216 min and 5.762 min, respectively, with a resolution of 10.10. The method demonstrated linearity in the range of 5-30 µg/mL for FAM and 2.5-15 µg/mL for DOM, with correlation coefficients r2 of 0.999 for both drugs. The method was validated as per ICH guidelines, showing excellent accuracy (recovery 99.45%-99.73% for FAM and 99.33%-100% for DOM), precision (RSD < 2%), and robustness. Forced degradation studies under acid, alkali, oxidative, thermal, and photolytic conditions confirmed the stability-indicating nature of the method. FAM was more sensitive to alkali hydrolysis, while DOM showed sensitivity to both acid and alkali hydrolysis. The method was successfully applied to the analysis of commercial tablet formulations, with no interference from excipients. The developed RP-HPLC method is simple, rapid, and reliable, making it suitable for routine quality control and stability studies of FAM and DOM in combined dosage forms.
Phytochemical screening and In-vitro evaluation of kiwi fruit
The fruit of Actinidia deliciosa (A. Chev.) C.F. Liang & A.R. Ferguson, commonly known as kiwifruit, is often referred to as "China’s miracle fruit" and the "Horticultural wonder of New Zealand." It is widely recognized for its exceptional bioactive properties that contribute to various health benefits. Kiwifruit promotes healthy skin and improved sleep due to its rich antioxidant and serotonin content. Additionally, it supports cardiovascular health and regulates blood pressure, being a valuable source of potassium, fiber, and antioxidants. Its antioxidant properties aid in anti-aging and blood purification, while its antihyperglycemic compounds may have potential antidiabetic effects. This study aimed to analyze the biochemical composition of kiwifruit and assess its antioxidant and antihyperglycemic potential. Chemical profiling of kiwifruit extracts prepared in ethanol and methanol solvents confirmed the presence of steroids, cardiac glycosides, terpenoids, flavonoids, and carbohydrates. Antioxidant activity was evaluated using the 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical inhibition assay, while the α-amylase inhibitory assay was conducted using α-amylase from Aspergillus oryzae. Among the two extracts, the methanolic extract (MKE) exhibited the highest inhibitory activity against both DPPH free radicals and α-amylase compared to the ethanolic extract (EKE). The IC50 values, representing the concentration required for 50% inhibition, were determined for both extracts. For the DPPH scavenging assay, the IC50 value was 4.2 ± 0.073 mg/mL for MKE and 3.14 ± 0.153 mg/mL for EKE. Meanwhile, in the α-amylase inhibition assay, the IC50 values were 1.53 ± 0.158 mg/mL for MKE and 2.05 ± 0.639 mg/mL for EKE. Kinetic analysis indicated that both MKE and EKE exhibited a competitive mode of inhibition toward α-amylase.
Designing Characterization and Bioaccumulation of Nanomaterials for Degradation of Environmental Pollutants
Environmental pollution, particularly from dyes and pigments, degrades water quality and poses health risks. Conventional water treatment systems often fail to address localized dye contamination, necessitating advanced decentralized solutions. This study explores the synthesis and characterization of six novel molybdenum and tin-based nanomaterials like MoO3, MoS2, and SnS2 nanoparticles, along with their core-shell nanocomposites incorporating CoMnFe2O4 designed for efficient dye degradation under visible LED light. The nanomaterials were synthesized using the hydrothermal method and characterized through Raman Spectroscopy, FTIR, HRTEM, XRD, and UV-DRS. Structural analysis confirmed varied morphologies and crystallite sizes ranging from 4 to 32 nm. Optical band gap measurements indicated enhanced photocatalytic properties, attributed to oxygen vacancies and intercalation effects. These specific nanocomposites, highlight their potential as effective, eco-friendly photocatalysts for environmental pollutant removal.
Copyright (c) 2024 Author https://creativecommons.org/licenses/by-nc/4.0
Development and Validation of a New RP-HPLC Method for the Simultaneous Estimation of Moexipril and Hydrochlorothiazide acid in Pharmaceutical Dosage form as Per ICH guidlines
This research work verified a HPLC technique for the concurrent identification of Moexipril & Hydrochlorothiazide in formulations. The technique demonstrated high specificity, with a resolution greater than 2 & % assay results of 101% for Moexipril &98.9% for Hydrochlorothiazide. Linearity was confirmed over the range of 20 to 100 µg per ml, with R² of 0.9999 & 0.9989, respectively. Precision was verified with %RSD values of 0.2% & 1.4%, & accuracy was supported by recovery studies yielding mean recoveries of 98.33% & 99.4%. Degradation studies indicated stability under various stress conditions, with minimal degradation (≤ 2.72%). Overall, the technique is robust & suitable for regular analysis in QC laboratories.
Analytical Method Development and Validation for the Ipragliflozine and Saxagliptin by using RP-HPLC in Pharmaceutical Dosage Forms as per ICH guidelines
This research works the advancement & verification of a RP-HPLC technique for the concurrent quantification of Ipragliflozine & Saxagliptin in formulations. The optimal chromatographic conditions were established using an INTERSIL C18-EP column with a MP of ACN & potassium phosphate buffer (pH 5) in a 70:30 ratio, a flow of 1 ml per min, & detection at 254 nm. The method was systematically verified for various parameters, including assay, linearity, precision, intermediate precision, accuracy, LOD, (LOQ, & robustness. The results demonstrated a strong correlation coefficient for linearity, with acceptable precision and accuracy across different concentrations. The LOD and LOQ for Ipragliflozine were determined to be 0.022 µg per ml and 0.076 µg per ml, respectively, while for Saxagliptin, they were 0.020 µg per ml and 0.075 µg per ml. Robustness testing confirmed method reliability under varied conditions, including flow speed & MP composition. Overall, the advancement HPLC technique is efficient, reproducible, and suitable for regular analysis of Ipragliflozine & Saxagliptin in QC laboratories, ensuring accurate dosage determination in preparations.
Development and Validation for Concurrent Identification of Docetaxel and Fosamprenavir in Pharmaceutical Dosage Forms by using RP-HPLC
This research work details the advancement & validation of an HPLC technique for the simultaneous estimation of Docetaxel & Fosamprenavir. Utilizing a Thermo Scientific Hypersil C18 column, the technique employs a MP of 50% Na3PO4 buffer (pH 5) & 50% MeOH, with a flow of 1.0 mL per min and detection at 245 nanometer. System suitability tests showed a tailing factor below 2.0 and theoretical plates above 2000, confirming the method’s reliability. Validation parameters included assay, scale of linearity, precision, ID precision, accuracy, LOD, LOQ, & robustness. The assay demonstrated high precision with %RSD within acceptable limits. Linearity was confirmed over a concentration range of 20 to 100 ppm for both drugs, with a strong correlation coefficient. Accuracy was validated through recovery studies at 50%, 100%, and 150% concentrations, while robustness assessments confirmed the method’s reliability under variations in flow &MP ratio. This optimized HPLC technique is suitable for regular analysis of Docetaxel & Fosamprenavir, offering a reliable, efficient, and reproducible approach for pharmaceutical quality control.
Development and Validation of a New RP- HPLC Method for the Zilucoplan in Pharmaceutical Dosage form as Per ICH Guidelines
The validation and reliability of a newly developed RP-HPLC method for quantifying zilucoplan in its pharmaceutical form, adhering to ICH guidelines. The method demonstrates specificity, accuracy, precision, and linearity within defined parameters. Robustness was confirmed through stress tests, ensuring suitability for routine quality control. Validation parameters, including system suitability, method precision, and stability testing, meet ICH criteria. Thus, this RP-HPLC method is a dependable tool for assessing zilucoplan quality, bolstering patient safety and drug efficacy assurance.
Synthesis, Characterization and In-vitro Anti-Inflammatory Activity of Methoxydibenzofuran -1,3-Thiazole-Carboxamide Derivatives.
The dibenzofuranthiazole group encompasses a well-established array of molecules that have yielded pharmacologically and biologically active agents with diverse heterocyclic and linear structures. Despite the potency of existing drugs like Tetomilast, Oglemilast, and Ciliomilast as anti-inflammatory agents, they are associated with significant side effects such as nausea, vomiting, and gastric acid secretion. Moreover, many contemporary standard drugs exhibit undesirable effects, including drug resistance, highlighting the urgent need for newer agents with improved potency and fewer adverse reactions. This study aimed to explore a set of new compounds synthesized through a four-step procedure involving coupling reactions. The purity of all synthesized derivatives was verified primarily through melting point, thin-layer chromatography, and FTIR spectroscopy, complemented by 1HNMR and Mass spectra studies. Additionally, the anti-inflammatory activities of the synthesized compounds were assessed using the protein denaturation assay method. The yields of all synthesized compounds ranged from 54% to 87%, demonstrating a moderate inhibition effect. Notably, compounds 4c, 4d, 4e, 4f, 4g, and 4h exhibited promising activity compared to the standard drug diclofenac sodium at a low concentration (100 µg/ml), with inhibition percentages ranging from 26.70% to 38.54%, surpassing diclofenac sodium's inhibition rate of 25.31 µg/ml. Particularly, compound 4d demonstrated significant inhibitory properties across all concentrations tested. This experiment suggests that the anti-inflammatory activity of dibenzofuranthiazole carboxamide derivatives is primarily attributed to halogenic derivatives with para substitution. Fluoro and chloro substitutions were identified as key enhancers of activity, along with methoxy derivatives bearing meta substituents exhibiting moderate activity.
Analytical method development and Validation for the Estimation of Avacopan in bulk and capsuledosage form by RP-HPLC
In the modern pharmaceutical industry, high-performance liquid chromatography (HPLC) is the major and integral analytical tool applied in all stages of drug discovery, development and production. It is ideal for the analysis of many drugs in both dosage forms and biological fluids due to its simplicity, high specificity and good sensitivity. A new method was established for estimation of Avacopan RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Avacopan. The maximum absorbance was found to be at 257 nm and the peak purity was excellent. Injection volume was selected to be 10µl which gave a good peak area. The column used for study was Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm because it was giving good peak. Ambient temperature was found to be suitable for the nature of drug solution. The flow rate was fixed at 1.0ml/min because of good peak area and satisfactory retention time. Mobile phase is Acetonitrile: Water (70:30% v/v) was fixed due to good symmetrical peak. So this mobile phase was used for the proposed study. Run time was selected to be 2.21 min and Retention Time found to be 2.286, % RSD was reported as 0.663419. The Minimum concentration level at which the analyte can be reliable detected (LOD) & quantified (LOQ) were found to be 0.05 & 0.15 µg/ml respectively.. Avacopan was degraded in acidic, basic & 3 % hydrogen peroxide & stable at thermal & light stress conditions.The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in Flow rate and Mobile phase composition separately and analysis being performed by different analysts. The suggested RP-HPLC method can be used for routine analysis of Avacopan in API and Pharmaceutical dosage form.