Multisource or generic drugs represent an important decrease in treatment cost for multiple diseases, which improves patient's medicine access. However, the therapeutic equivalence between original drugs (innovator) and generic or multisource drugs need to be demonstrated. Bioequivalence represents drug efficacy and higher security for patients, and it is considered as a fundamental factor for product commercialization. This work main objective was to make a comparison between the dissolution profiles of the original and multisource metformin hydrochloride tablets commercialized in Costa Rica. We used a validated analytical method to quantify metformin in dissolution medium, a phosphates buffered solution of pH (6.8 ± 0.05). The obtained results demonstrated products interchangeability using the model-independent similarity factor (f2) and difference factor (f1) criteria.
Metformin hydrochloride is a hypoglycemic agent used for type II Diabetes Mellitus treatment, and one of the most used to manage it. The objective of the present work was the development and validation of an analytical method to quantify metformin hydrochloride in the dissolution medium by UV spectrophotometry. Linearity and range, accuracy and precision were the validation process parameters. Validation process results showed the analytical method was easy, quick, secure and, furthermore, a linear, accurate and precise method in the studied concentrations range. Therefore, it is a reliable analytical method.
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