The present research work aims to develop a novel ultraviolet UV spectrophotometric method for the determination of Amlodipine Besylate using Benzoyl Chloride as a derivatizing agent, which is simple, rapid, sensitive, selective, and accurate method for the spectrophotometric determination of Amlodipine Besylate in powder form. Synthesis is based upon the Schotten Baumann Reaction. In this method, derivatization of aliphatic amine group of Amlodipine Besylate carried out with benzoyl chloride and aqueous sodium hydroxide (NaOH).The λmax was found to be 237 and 226nm for assay of Amlodipine Besylate and synthesised product respectively. The linearity was found in concentration range of 1-10 μg/ml. The correlation coefficient (r2)was found 0.9985. The regression equation, intercept (a) and slope (b) was found as Y=0.0762x - 0.0077, 0.0077 and 0.0762 respectively. Method was developed and validated as per ICH guidelines for linearity, accuracy, precision, LOD, LOQ, interday and intraday. The LOD and LOQ for estimation of Amlodipine besylate were found as 0.2367, 0.7178 respectively. Recovery of Amlodipine besylate was found to be 93.30%.The proposed method is found to be simple, rapid, selective and highly sensitive than most of the Spectrophotometric methods available in literature.
Keywords: Derivatization, Ultraviolet spectrophotometry, Amlodipine besylate, Validation, Synthesis