UV Spectrophotometric Method Development and Validation for Amlodipine Besylate in Bulk and Tablet Dosage Form

Abstract

Analytical method development and validation is important in development of pharmaceutical preparations. In present study a spectroscopic method for determination of Amlodipine besylate in pharmaceutical dosage form has been developed and validated. The wavelength maxima of Amlodipine besylate was found to be 360nm. Ethanol was used as a solvent. Amlodipine besylate obeys beers law in the concentration range of 5-40μg/ml. The line equation obtained is y = 0.0136x + 0.001 with correlation coefficient (r2) of 0.998. Interday, intraday variations were studied to determine the precision of the proposed method and was found to be with good precision as the %RSD was less than 2%. The assay of 2 different marketed formulation (A and B) has been performed and the % assay of A and B was found to be 98.3% and 99.2% respectively. The sensitivity of the method was determined by LOD and LOQ was found to be 0.08123µg/ml and 0.2461µg/ml respectively. The method employed the parameters like linearity, accuracy, precision, sensitivity, robustness, ruggedness and all the procedures were as per ICH guidelines.