Analytical Method Development and Validation for Amlodipine Besylate Using RP-HPLC

AbstractAmlodipine Besylate is a calcium channel blocker commonly prescribed for the management ofhypertension and angina pectoris. Accurate and reliable analytical methods are essential forquality control in pharmaceutical formulations. This study focuses on the development andvalidation of a novel High-Performance Liquid Chromatography (HPLC) method for thequantitative estimation of Amlodipine Besylate in tablet dosage forms. The chromatographicseparation was achieved using a C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phaseconsisting of phosphate buffer (pH 3.0) and acetonitrile in the ratio of 65:35 v/v, at a flow rate of1.0 mL/min. Detection was carried out at 238 nm using a UV detector. The method was validatedaccording to ICH Q2 (R1) guidelines, covering parameters such as linearity, accuracy, precision,specificity, robustness, and system suitability. The linearity of the method was established in therange of 10–60 μg/mL with a correlation coefficient (R2) of 0.999. The method demonstratedacceptable accuracy (recovery between 98.5%–101.5%), precision (RSD < 2%), and robustnessunder varied experimental conditions. The limit of detection (LOD) and limit of quantitation(LOQ) were found to be 0.53 μg/mL and 1.61 μg/mL, respectively. The developed HPLCmethod proved to be simple, sensitive, precise, and suitable for routine analysis of AmlodipineBesylate in pharmaceutical dosage forms.