Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets

Abstract

The purpose of this study was to develop and validate a discriminative dissolution method for Metformin film-coated tablet with immediate-release of the active substance that belongs to class III of the Biopharmaceutical Classification System (BCS). Different conditions such as: type of dissolution medium, volume of dissolution medium, rotation speed, apparatus and filter suitability were evaluated. The most discriminative release profile for Metformin film-coated tablet was accomplished by using Apparatus II (paddle), 1000 mL of phosphate buffer pH 6.8 as dissolution medium, maintained on 37 ± 0.5 °C and rotation speed of 75 rpm. The quantification of the released active substance was performed by UV-Vis spectrophotometry, at 232 nm. Acceptance criteria for not less than 80% (Q+5%) of the labeled content for 45 minutes were set. The dissolution method was validated according to current international guidelines using parameters: specificity, accuracy, precision, linearity, robustness and stability of the solutions, found to be meeting the predetermined acceptance criteria. A developed dissolution method has discriminatory power to reflect the characteristics of the medicinal product and is able to distinguish any changes related to quantitative formulation and can be also applied for routine batch testing.