Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia

Abstract

The objective of this study was to evaluate the physicochemical quality control parameters and pharmaceutical equivalence of amlodipine besylate generic tablets and capsules with the innovator brands (Norvasc and Amlor, respectively) available in Riyadh, Saudi Arabia. Five brands of amlodipine besylate tablets and capsules (5 mg) were compared via quality control tests according to the United States Pharmacopoeia (i.e., hardness, thickness, diameter, weight variation, uniformity of dosage content, friability, disintegration, dissolution by ultraviolet spectrophotometry, and Fourier-transform infrared spectroscopy (FTIR)). All selected brands were found to comply with USP-NF specifications concerning weight variation, hardness, friability, disintegration time, FTIR, and drug content analysis. The dissolution profiles for all products satisfied the USP-NF specifications. Regarding, model-dependent data, all the tested brands followed the Higuchi model of release. Using the model-independent approach (i.e., similarity factor analysis), all products were considered similar except for one generic product (ABC-3). All brands had no significant difference in mean dissolution efficiency compared to the innovator, except ABC-3.