Quality Assurance and In-vitro Bioequivalence Analysis of Amlodipine Besylate Tablets

Abstract

The proliferation of generic brands in the local pharmaceutical market makes it increasingly difficult for health professionals and patients to choose the optimal drug. The study aimed to assess the physicochemical parameters of generic amlodipine besylate tablets utilizing in-vitro testing to eliminate health hazards and maximize safety. Five brands (A, B, C, D, and E) of amlodipine besylate tablets (5 mg) were examined for six in-vitro tests; thickness, hardness, friability, uniformity of weight, disintegration, dissolution, and thin layer chromatography (TLC). The dissolution test revealed that Brand D had the highest percentage of drug release at 5 minutes (106.2%), followed by Brand E (103.2%), A (70.7%), B (64.4%), and C (61.0%), respectively. The spectrophotometric measurement was carried out at 240 nm. All five brands satisfied the British Pharmacopeia standard for uncoated tablet weight homogeneity (less than 5% variance) and disintegration within 15 minutes. Brand A has the longest disintegration time (4.37 minutes), whereas Brand B has the shortest (3.05). Brand E had the maximum hardness of 8.7 kg/cm², and Brand B had the lowest hardness of 3 kg/cm². All five brands had a friability percentage of less than 1%, with bread B having the highest (0.91%) and brand E, lowest (0.10%), all tablets crumbled after 15 minutes. All brands passed the quality assessment test. Conclusion: The Quality Assurance and in-vitro bioequivalence assay methods used in this study are dependable, simple, and inexpensive, and they can be used consistently to evaluate amlodipine tablets and other solid-dosage pharmaceutical products.