Dissolution Method Development for Combined Dosage form of Amlodipine Besylate and Atenolol by Spectrophotometric Analysis

Abstract

A new UV-Vis spectrophotometric method have been developed and validated for simultaneous estimation of Amlodipine besylate and atenolol. Using this method a dissolution method has also been developed for immeadiate release tablet dosage forms of Amlodipine besylate and atenolol fixed dose combination. Dissolution profiles of different brands were also been compared using one way ANOVA test. In UV-Vis spectrophotometric method, linear correlation was obtained between concentration and absorbance in the range of 1-8 μg/ml and 10-80 μg/ml for Amlodipine besylate and atenolol at 364.4 nm and 238.2 nm respectively. The % recovery for accuracy study was in the range of 98.83 ± 3.71 to 100.84 ± 1.71 for amlodipine besylate and 98.92 ± 2.06 to 100.12 ± 2.06 for atenolol. The method was found to be accurate, precise and repeatable with low limit of detection and limit of quantification. In dissolution method, established conditions “900 mL of 0.01M HCl as dissolution medium, using a paddle apparatus at a stirring rate of 75 rpm”, used to get dissolution profiles of different brands. From the release profile it was found that all the brands give % release more than 75% and 90% for Amlodipine besylate and atenolol respectively which meets the specifications. The obtained release profiles were statistically compared using one way ANOVA test. From the results it was found that the brands have significant difference within and between treatments, as calculated F value is more than critical F value. These methods can be used for routine quality control process in the laboratory.