Validation of methodology for assay, pharmaceutical equivalence, and comparative dissolution profile for tablets containing amlodipine besylate

ABSTRACT

The amlodipine besylate is indicated as a first choice in the treatment of hypertension. Many similar and generic drugproducts companies were able to bring out to the market dosage forms containing amlodipine besylate with lowerprices. In this context, the aim of this work was to validate a simple method for the determination of amlodipinecontent in tablets by ultraviolet spectrophotometry and to perform pharmaceutical equivalence and dissolution profilestudies for three similar and one generic drug products and their respective innovator tablet containing amlodipine(5 mg). The developed method for the determination of amlodipine content proved to be linear, precise, accurate,robust, and appropriate for employment in the quality control of tablets containing amlodipine besylate. The reference(R), similar (S1, S2, and S3), and generic (G) drug products all fulfilled the specifications for the tests of identification,average weight, hardness, friability, disintegration, drug content, content uniformity, and dissolution. However, incomparative dissolution profile studies, the dissolution efficiency of products G and S2 was statistically different fromproduct R, which may indirectly lead to the unsuitable bioavailability and therapeutic inefficacy. Thus, there is a needfor tighter legislation and inspection regarding the quality of pharmaceutical products already on the market.