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Original Article

J App Pharm Sci. 2019; 9(11): 93-100

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

Renata Micheli Martinez, Jenifer Freitas da Silva, Larissa Regina Jorge, Rhye Lessa Ishikawa, Ana Paula Novelli, Talita Laiane Cardoso Cezar, Sandra Regina Georgetti, Marcela Maria Baracat, Rúbia Casagrande.

The amlodipine besylate is indicated as a first choice in the treatment of hypertension. Many similar and generic drug products companies were able to bring out to the market dosage forms containing amlodipine besylate with lower prices. In this context, the aim of this work was to validate a simple method for determination of amlodipine content in tablets by ultraviolet spectrophotometry, and to perform pharmaceutical equivalence and dissolution profile studies for three similar and one generic drug products and their respective innovator tablet containing amlodipine (5 mg). The developed method for to 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, in comparative dissolution profile studies, dissolution efficiency of products G and S2 were statistically different from product R, which may indirectly lead to the unsuitable bioavailability and therapeutic inefficacy. Thus, there is a need for tighter legislation and inspection regarding the quality of pharmaceutical products already on the market.

Key words: amlodipine, generic, similar, drug products, quality control, validation.

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