Analytical Method Development And Validation Of Azelnidipine In Bulk Drug And It’s Pharmaceutical Dosage Form By RP-HPLC Method

Abstract

The precise and efficient quantification of active pharmaceutical ingredients (API) in bulk drugs and their dosage forms is essential in pharmaceutical quality control. This study aims to develop and validate a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for Azelnidipine, a calcium channel blocker used in the treatment of hypertension. The method was validated as per the International Council for Harmonization (ICH) Q2 (R1) guidelines, ensuring compliance with the parameters of specificity, accuracy, precision, and linearity, limit of detection (LOD), limit of quantification (LOQ), robustness, and system suitability. The optimized chromatographic conditions employed a C18 column with Acetonitrile: Phosphate Buffer (70:30, v/v) as the mobile phase, with UV detection at 254 nm. The method demonstrated excellent linearity over the concentration range of 10-200 μg/mL (r² > 0.999), with a retention time of 8.56 minutes for Azelnidipine. The method was further tested for the analysis of marketed formulations, yielding consistent results with % recoveries ranging from 98% to 102%. LOD and LOQ were determined to be 0.2 μg/mL and 0.637 μg/mL, respectively, confirming the method's sensitivity. The method is reliable and reproducible for the routine analysis of Azelnidipine in quality control laboratories, ensuring the safety and efficacy of pharmaceutical products.