Journal of Pharmaceutical and Biomedical Analysis Letters
Formulation and Evaluation of Ivabradine Oral Thin Films
In present study oral thin films of Ivabradine were developed to have a faster on set of action. The oral thin films were developed by using polymers HPMC E5, HPMC E 15 and PVP K90.Oral thin films were prepared by employing solvent casting method. Propylene glycol was selected as permeation enhancer and plasticizer. Drug excipient compatibility studies were carried out by using FTIR, and it was observed that there were no interactions. Formulations were prepared with the varying concentrations polymers ranging from F1-F6, and all the formulations were evaluated for various physical parameters Physical appearance, Weight variation, Thickness, Folding endurance, Tensile strength, Drug content, Moisture uptake, Moisture content and all the results were found to be were found to be with in the pharmacopeial limits, in-vitro drug release studies by using dialysis membrane. Among all the 6 formulations F1 formulation which contain HPMC E15 300mg and shown 97.2.% cumulative drug release within 30 min. And compared to HPMC E15, HPMC E5 and PVP K90, HPMC E 15 showed better drug release profile.
Copyright (c) 2026 Author https://creativecommons.org/licenses/by-nc/4.0
Biosynthesis of silver nano particles of herbal plant extracts and characterisation by using UV and FTIR analysis
The present study explores the green synthesis of silver nanoparticles (AgNPs) using aqueous extracts of Zingiber officinale (ginger rhizome), Carica papaya (papaya seeds), and Camellia sinensis (green tea leaves). Extracts were subjected to phytochemical screening, total phenolic content (TPC) estimation, and characterization of AgNPs by UV–Vis and FTIR. Their biological efficacy was evaluated through catalytic degradation of methylene blue, antioxidant activity (DPPH assay), and antimicrobial studies. Ginger showed the highest TPC (75.65 mg GAE/mg), efficient AgNP formation, and strong antioxidant, antimicrobial, and catalytic activities. Papaya seeds, with lower TPC (13.7 mg GAE/mg), produced AgNPs with moderate antioxidant and antimicrobial effects, particularly against E. coli. Green tea (36.64 mg GAE/mg) yielded stable AgNPs with significant antioxidant, catalytic, and antibacterial activity. These findings highlight plant-mediated AgNPs as eco-friendly nanomaterials with biomedical and environmental potential, with ginger demonstrating the strongest overall performance.
AI-Assisted Identification and Quantification of Pharmaceutical Impurities using HPLC Chromatographic Data
Pharmaceutical impurities present in active pharmaceutical ingredients (APIs) and finished drug products can have profound impacts on drug safety, efficacy, and stability. Regulatory authorities such as the International Council for Harmonisation (ICH), U.S. Food and Drug Administration (FDA), and European Medicines Agency (EMA) require stringent impurity identification and quantification to ensure drug quality and patient safety. High-Performance Liquid Chromatography (HPLC) remains the most common analytical method for impurity profiling, thanks to its high sensitivity, precision, and ability to separate complex mixtures. However, traditional HPLC data interpretation relies heavily on manual analysis, making it time-consuming, operator-dependent, and prone to human error. Artificial Intelligence (AI) and Machine Learning (ML) have emerged as transformative tools for automating chromatographic data analysis, enabling rapid and accurate impurity detection, identification, and quantification. AI algorithms can efficiently process large chromatographic datasets, identify subtle peak patterns, correct baseline drifts, and predict retention behaviours under various chromatographic conditions. This comprehensive article explores the integration of AI approaches into HPLC impurity profiling, covering theoretical foundations, data preprocessing, peak recognition, automated quantification, and future implications for pharmaceutical quality control and regulatory compliance.
High-Performance Liquid Chromatography (HPLC)
Copyright (c) 2026 Authors https://creativecommons.org/licenses/by-nc/4.0
Phytoconstituents as Potential Anticancer Agents: Mechanisms, Evidence, and Therapeutic Prospects
Cancer remains a major global health challenge despite advances in diagnosis and treatment. Conventional therapies such as chemotherapy and radiotherapy are often limited by systemic toxicity, resistance development, and damage to healthy tissues. Phytoconstituents, bioactive secondary metabolites derived from medicinal plants, have gained considerable attention as potential anticancer agents due to their multi-targeted mechanisms, relative safety, and chemopreventive properties. This study reviews the classification, molecular mechanisms, experimental evidence, clinical relevance, advantages, and limitations of phytoconstituents in cancer therapy. Evidence from in vitro, in vivo, and clinical studies indicates that compounds such as curcumin, resveratrol, epigallocatechin gallate (EGCG), genistein, sulforaphane, silymarin, vincristine, vinblastine, and paclitaxel modulate key signaling pathways including NF-κB, PI3K/Akt, MAPK, p53, VEGF, and STAT3. These compounds exert anticancer effects through apoptosis induction, cell cycle arrest, inhibition of angiogenesis, suppression of metastasis, epigenetic modulation, and targeting of cancer stem cells. Although limitations such as poor bioavailability and insufficient large-scale clinical validation persist, advancements in nanotechnology and targeted drug delivery systems offer promising solutions. Phytoconstituents represent a valuable bridge between traditional medicine and modern oncology and may contribute significantly to future cancer prevention and therapy strategies.
Development and Validation of a Liquid Chromatography Method for the Simultaneous Estimation of Sulfadoxine and Pyrimethamine in Combined Dosage Forms
The final method employed a Platisil C18-ODS column (250×4.6 mm, 5 µm) with a mobile phase of 50% 0.1% formic acid (pH 4.5) and 50% methanol, at a flow rate of 1.0 ml/min, and UV detection at 230 nm. System suitability parameters such as retention time, theoretical plates, and tailing factor were within acceptable limits, confirming the method’s efficiency and reliability. Validation was performed according to ICH Q2(R1) guidelines, demonstrating excellent analytical performance. Assay results showed drug content of 99.1% for Sulfadoxine and 98.6% for Pyrimethamine. Linearity was observed over wide concentration ranges with correlation coefficients of 0.9997 and 0.9996, respectively. Precision and intermediate precision studies yielded %RSD values below 2%, indicating high repeatability and ruggedness. Recovery studies confirmed accuracy within the 98–102% range, while LOD and LOQ values (0.02 µg/ml for Sulfadoxine and 0.05µg/ml for Pyrimethamine) highlighted the method’s sensitivity. Robustness testing under slight variations in flow rate and mobile phase composition showed consistent results, affirming the method’s suitability for routine quality control of combined dosage formulations.
QBD-Based Analytical Method Development and Validation for the Simultaneous Estimation of Voglibose and Metformin Using RP-HPLC
A scientifically rigorous and precise reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed using a Quality by Design (QbD) approach for the simultaneous estimation of Voglibose and Metformin in fixed-dose combination formulations. The method was systematically optimized through Design of Experiments (DoE), evaluating critical parameters such as flow rate, buffer pH, and organic solvent ratio for their impact on chromatographic responses like resolution and tailing factor. Statistical analysis via ANOVA confirmed the significance of the quadratic model in achieving optimal separation. The final method employed a Zorbax C18 column with phosphate buffer (pH 4.5) and acetonitrile (45:55 v/v) as the mobile phase, operating at a flow rate of 1.2 mL/min and detection at 225 nm. This setup yielded excellent peak separation with a resolution of 10.10 between the analytes. Validation was conducted in accordance with ICH Q2(R1) guidelines, demonstrating outstanding linearity for Metformin (25–125 µg/mL) and Voglibose (0.1–0.5µg/mL), with correlation coefficients of 0.9998 and 0.9994, respectively. Precision studies confirmed repeatability and intermediate precision (%RSD < 2%), while accuracy was validated through high recovery rates (99.4% for Voglibose and 99.6% for Metformin). Sensitivity was affirmed with acceptable LOD and LOQ values. This QbD-driven RP-HPLC method provides a robust, validated, and regulatory-compliant solution for simultaneous estimation of Voglibose and Metformin in pharmaceutical applications
QBD-based RP-HPLC Method Development and Validation for Thioacetazone and Isoniazide in Pharmaceutical Dosage Forms as per ICH Guidelines
A novel and comprehensive High-Performance Liquid Chromatography (HPLC) method was developed and optimized for the simultaneous estimation of Isoniazid and Thioacetazone in pharmaceutical formulations. Method optimization was achieved using a Box-Behnken design coupled with response surface methodology, evaluating critical chromatographic parameters such as flow rate, buffer ratio, and buffer pH. The optimized conditions employed a Platisil C18 column (150×3.0 mm, 3μm) with a mobile phase of 0.1% orthophosphoric acid buffer (pH 3.5) and methanol (40:60 v/v), at a flow rate of 0.8 mL/min and detection at 258 nm. System suitability tests confirmed acceptable resolution (≥2), tailing factor (≤2), and theoretical plate count (≥2000), ensuring reliable separation and peak symmetry for both analytes. The method was rigorously validated in accordance with ICH guidelines, demonstrating excellent linearity for Isoniazid (10–50 µg/mL, R² = 0.9998) and Thioacetazone (5–25 µg/mL, R² = 0.9995). Precision studies yielded %RSD values below 2%, confirming reproducibility under varied conditions. Sensitivity was established through low LOD and LOQ values, while recovery studies at multiple concentration levels (50%, 100%, 150%) showed accuracy within 98–102%. Robustness was maintained despite deliberate variations in chromatographic parameters. Overall, the validated method is accurate, precise, sensitive, and robust, making it highly suitable for routine quality control of Isoniazid and Thioacetazone in pharmaceutical dosage forms.
New Validated Stability Indicating RP-HPLC Method Development for Simultaneously Estimation of Betamethasone and Calcipotriene in Its Bulk and Pharmaceutical Dosage Form
This study focused on developing and characterizing floating microspheres of Propranolol HCl, aiming to enhance gastric retention and sustained drug release. A UV-Visible spectrophotometric method was validated for drug quantification in 0.1N HCl at 256 nm, exhibiting strong linearity over the concentration range of 2 to 10 µg/ml. Compatibility studies using FTIR spectroscopy confirmed no chemical interactions between the drug and polymers, ensuring formulation stability. The prepared microspheres showed high percentage yields between 81.58% and 95.50%, with drug entrapment efficiency improving as polymer concentration increased due to higher solution viscosity reducing drug diffusion during formation. Further evaluations revealed that the microspheres exhibited satisfactory swelling behavior and mucoadhesive properties essential for prolonged gastric residence. In vitro release experiments demonstrated efficient and controlled drug liberation over 12 hours, with release kinetics fitting diffusion-controlled models such as zero-order, first-order, Higuchi, and Korsmeyer-Peppas. Optimized formulations showed promising potential for sustained release and enhanced gastroretention, which could improve therapeutic effectiveness and patient adherence.
Copyright (c) 2025 Author https://creativecommons.org/licenses/by-nc/4.0
Method Development and Validation for the Simultaneous Estimation of Sequinavir and Tipronavir by using HPLC
RS Method for Quantification of Imeglimin HCl in Its Pure and Tablet Dosage form by using RP-HPLC Technology
Preparation and Evaluation of Floating Beads of Propranolol Hydrochloride
Novel Therapeutic Options for Prevention and Management of Cancer
The high incidence of cancer may be caused by several factors, such as genetic mutations, environmental factors, insufficient physical activity, diverse lifestyles, unstable behaviors related to diet, smoking, and alcohol consumption. The current treatment methods for different stages of various cancers include chemotherapy, radiation therapy, and surgical procedures for solid tumors, or a combination of the above. Although these different treatment modalities can effectively reduce cancer, patients may also experience side effects. Radiation therapy runs the risk of causing DNA damage in surrounding healthy cells, which could potentially lead to new incidences of cancer. Similarly, although surgical intervention the primary treatment for solid tumors significantly improves patient survival, its success rate depends on the expertise of the surgeon and the availability of screening methods, including hospital imaging equipment. The introduction of chemotherapy was a milestone in cancer treatment. However, prolonged use of chemotherapy drugs, especially those affecting tumor cell metabolic pathways and signal transduction, can influence tumor occurrence, metastasis, drug response, recurrence, drug resistance, and cancer stem cells (CSCs). Traditionally, drug development involves preclinical research and clinical trials. Preclinical studies involve testing the efficacy, toxicity, pharmacokinetics, and pharmacodynamics of drugs in human tumor cells and animal models. Once the therapeutic efficacy of a drug has been determined, the drug moves into the clinical trial phase, which includes Phase I, II, and III human clinical trials, to determine the safety and effectiveness of the drug. As such, it takes 10–15 years and costs $1–2 billion to produce a new drug approved for clinical use.
Investigation of Antidiabetic and Anti-inflammatory Properties of Ghee through GC–MS Analysis
Ghee, a clarified form of butter traditionally used in Indian cooking and Ayurvedic medicine, has gained attention for its potential therapeutic benefits. This study explores the antidiabetic and anti-inflammatory properties of ghee through a comprehensive review of preclinical and clinical literature, alongside possible biochemical mechanisms. Ghee is rich in short-chain and medium-chain fatty acids, conjugated linoleic acid (CLA), and fat-soluble vitamins, which contribute to its bioactivity. Antidiabetic effects are primarily attributed to improved insulin sensitivity, modulation of lipid metabolism, and reduction in oxidative stress. Ghee has also demonstrated anti-inflammatory properties through the down regulation of pro-inflammatory cytokines and inhibition of COX-2 expression. These effects may support ghee’s role as a functional dietary component in managing chronic metabolic disorders.
Analytical Method Development and Validation for Simultaneous Estimaton of Azelnidipine and Telmisartan by RP-HPLC in Bulk and Tablet Dosage Forms
A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Azelnidipine and Telmisartan in its pure form as well as in combined marketed formulation. Chromatography was carried out on a Phenomenex Luna C18 (4.6mm×250mm) 5µm particle size column using a mixture of Methanol: Phosphate Buffer (pH-4.2) (37:63% v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260 nm. The retention time of the Azelnidipine and Telmisartan was found to be was 2.133, 3.692±0.02 min respectively. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Azelnidipine and 10-30mg/ml of Telmisartan. The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Integrated Analytical Quality by Design Approach for the Development and Validation of Liquid Chromatography Method for Simulataneous Estimation of Sulfadoxane and Pyrimethamine
This research evaluates a validated chromatographic method for analyzing sulfadoxine and pyrimethamine. A quadratic model was most effective for retention time analysis (p < 0.0001). System suitability met regulatory standards for resolution, theoretical plates, and tailing. The method was validated for assay, linearity, precision, intermediate precision, accuracy, LOD, and LOQ. Assay values were 99.79% (sulfadoxine) and 99.52% (pyrimethamine). Linearity showed strong correlation (r = 0.9996 and 0.9993, respectively). Precision was excellent (%RSD<1), and accuracy fell within 98–102%. LODs were 0.5µg/mL and 0.2µg/mL, while LOQs were 1.9 µg/mL and 0.8µg/mL. The method proved robust under varied conditions and is suitable for concurrent formulation analysis.
RP-HPLC Method Development and Validation for the simultaneous estimation of Meropenem and Vaborbactam in its pure and Dosage form
A robust and optimized chromatographic method for the simultaneous quantification of Meropenem and Vaborbactam was developed using Spurcil C18 Column (250×4.6mm, 5µm) with a flow rate of 1.0 ml/min, ensuring excellent peak separation and resolution. System suitability tests confirmed compliance with essential parameters such as resolution, tailing factor, and plate count, reinforcing the method's reliability. The retention times (RT) for Meropenem and Vaborbactam were 3.090 min and 4.215 min, respectively. Linearity assessments demonstrated strong correlation coefficients (>0.999), validating the accuracy of quantification across a concentration range of 10-50 µg/ml. Precision studies exhibited low %RSD values, confirming reproducibility, while accuracy investigations yielded recovery rates within 98-102%, ensuring method robustness. Further validation was performed to assess ruggedness and robustness, confirming method stability under varying chromatographic conditions, including flow rate and mobile phase composition variations. Despite these modifications, retention times remained consistent, reaffirming reproducibility. The method demonstrated high sensitivity, with limits of detection (LOD) and limits of quantification (LOQ) established at 0.01µg/ml for Meropenem and 0.02µg/ml for Vaborbactam. Intermediate precision studies verified assay reliability across different analytical systems and days, further validating its consistency. In conclusion, the developed HPLC method for Meropenem and Vaborbactam is precise, accurate, linear, sensitive, and robust, making it highly suitable for routine pharmaceutical analysis and quality control applications. Compliance with regulatory standards ensures reliable identification and quantification, providing an efficient and reproducible analytical solution for the quality assurance and validation of Meropenem and Vaborbactam formulations.
RP-HPLC Method Development and Validation of a Stability Indicating Cidofovir in Its Pure and Dosage Form
High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Cidofovir was done by waters HPLC with auto sampler and PDA detector. The buffer 1ml TFA in 1000ml water. Adjust this solution to pH 3 by using acid / base based on the PH of the resulted solution and Mix a mixture of above ACN 650ml (65%), 350 ml TFA (35%) and degas in ultrasonic water bath for 5 minutes. Filter through 0.45 µ filter under vacuum filtration. Inspire (150X4.6mm 5µm) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 230nm. The solutions were chromatographed at a constant flow rate of 1ml/min and Injection volume 20l, the run time 10min, the linearity range was found to lie from 20µg/ml to 50µg/ml of Cidofovir. The results obtained on the validation parameters met ICH and USP requirements. It inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis.
Screening the efficacy of compounds from Ghee to control cancer through GC-MS Analysis
Ghee, a clarified form of butter, holds a revered status in Ayurveda as the healthiest source of edible fat, known for its diverse therapeutic and nutritional benefits. Traditionally integrated into the daily Indian diet and religious rituals, ghee is considered essential for promoting longevity, enhancing memory, and supporting the nervous system. Its unique ability to act as a vehicle for transporting herbal constituents to deeper tissues further underscores its medicinal value. Ayurvedic texts suggest that ghee improves digestion, absorption, and assimilation, while also lubricating the nervous tissue and enhancing bodily flexibility. However, from a modern scientific perspective, caution is warranted regarding excessive consumption. Ghee is rich in saturated fatty acids (65%), monounsaturated fatty acids (32%), and polyunsaturated fatty acids (3%), which, in high intake, may elevate cholesterol levels and increase the risk of cardiovascular diseases. Additionally, the role of lipid peroxidation and free radical damage in chronic diseases and aging is well-documented, linking excessive fat intake to pathological conditions such as ischemia, inflammation, stroke, and carcinogenesis. Thus, while ghee offers numerous health benefits as per Ayurvedic tradition, its consumption should be balanced and moderated in the context of modern health guidelines.
Development of a Robust RP-HPLC Method for the Analysis of Ofloxacin and Nitazoxanide in Fixed-Dose Combination Products
A new method was established for simultaneous estimation of Ofloxacin and Nitazoxanide by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Ofloxacin and Nitazoxanide by using Xterra C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN (55:45%v/v) (pH was adjusted with orthophosphoric acid), detection wavelength was 255nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention times were found to be 2.399mins and 3.907mins. The % purity of Ofloxacin and Nitazoxanide was found to be 100.7% and 101.4% respectively. The system suitability parameters for Ofloxacin and Nitazoxanide such as theoretical plates and tailing factors were found to be 1.3, 5117.5and 1.4, 3877.3 the resolution was found to be 5.31. In compliance with ICH criteria, the analytical procedure was verified (ICH, Q2 (R1)) 4. According to the linearity investigation, the concentration ranges of ofloxacin and nitazoxanide were 20μg–100μg and 10μg–50μg. The correlation coefficient (r2) was 0.999 and 0.999, and the percentage mean recovery was 100% and 100.5%. The repeatability RSD was between 0.2 and 0.4 percent. For intermediate precision, the corresponding RSDs were 0.5 and 0.1
Development and Validation of a New RP-HPLC Method for the Estimation of Citalopram in Tablet Dosage Forms
A novel, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of citalopram in tablet dosage forms. The method utilized an Agilent Eclipse XDB C18 column (150 x 4.6 mm, 5 µm) with a mobile phase consisting of acetate buffer (pH 4.5) and acetonitrile in a 65:35 v/v ratio, pumped at a flow rate of 1.0 mL/min. Detection was carried out at 240 nm, and the retention time for citalopram was found to be 3.727 minutes. The method demonstrated excellent linearity in the concentration range of 25, 150 µg/mL (r² = 0.999). Validation studies confirmed the method's precision, accuracy, specificity, and robustness, with recovery values ranging from 98.65% to 101.72%. The limits of detection (LOD) and quantification (LOQ) were determined to be 1.125 µg/mL and 3.375 µg/mL, respectively. The method was successfully applied to quantify citalopram in commercial tablet formulations, with results showing 100.1% recovery of the labeled claim. Forced degradation studies under acidic, basic, oxidative, thermal, photolytic, and neutral conditions revealed that the method could effectively separate citalopram from its degradation products, indicating its stability-indicating capability. The proposed method offers advantages over existing methods, including shorter analysis time (8 minutes), higher sensitivity, and a wider linearity range. It is concluded that this RP-HPLC method is suitable for routine quality control analysis of citalopram in pharmaceutical formulations.
Copyright (c) 2025 Author https://creativecommons.org/licenses/by-nc/4.0/