Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Tamsulosin HCl and Tadalafil in Pharmaceutical Dosage Forms

Abstract

This research work outlines the optimization & validation of a HPLC method for the simultaneous analysis of Tamsulosin & Tadalafil. The optimized chromatographic conditions included the use of a Spursil C18-EP column with a MP composition of 70% per chloric acid & 30% ACN, a flow speed of 1.5 ml per min, & detection at 223 nm. SST confirmed that all parameters, including resolution (greater than 2), theoretical plates (above 2000), & tailing factor (below 2), were within acceptable limits. The assay results indicated a % assay of 99.90% for Tamsulosin& 101% for Tadalafil. The method exhibited linearity in the concentration extent of 1.6-8 µg per ml for Tamsulosin& 20-100 µg per ml for Tadalafil, with R2 exceeding 0.999. Precision, ID precision, & accuracy studies demonstrated low %RSD values (0.17% for Tamsulosin&0.14% for Tadalafil), indicating robustness &reliability. LOD were established at 0.026 µg per ml for Tamsulosin & 0.027 µg per ml for Tadalafil, while LOQ were 0.092µg per ml & 0.093 µg per ml, respectively. The technique proved resilient against variations in flow speeds& MP composition. Additionally, degradation studies assessed the stability of both compounds under various conditions, confirming their robustness. Overall, the validated HPLC technique is suitable for regular QC of Tamsulosin & Tadalafilin formulations.