Development and Validation of New Discriminative Dissolution Method for Dapagliflozin Tablets

Abstract

In this study, we aimed to find out how well dapagliflozin worked by creating and testing a new way to dissolve the pills. We considered a great many factors, including the quantity of dissolved liquid, the liquid’s composition, and the rotational speed of the paddle. Apparatus II, or the paddle, was employed to get the perfect in-vitro breakdown profile. The dissolving media consisted of 900 mL of phosphate buffer with a pH of 6.8, and the machine was spun at a speed of 50 revolutions per minute. For the purpose of assessing the drug release method’s properties, high-performance liquid chromatography (HPLC) was used. Regarding the dissolving procedure, which was found to be in compliance with regulations, all applicable laws were followed, including those of the Food and Drug Administration (FDA). Extensive evaluation of several attributes, including precision, sensitivity, accuracy, and stability, led to the conclusion that the outcomes were satisfactory. We examined the patterns of breakdown for many entities using a range of methodologies, including model-dependent methodology, model-independent methodology, and analysis of variance (ANOVA). According to the results, there was a great deal of overlap between the two things. Dapagliflozin tablet production and quality control could benefit from the melting test that was given and shown. This is because it can distinguish among the examined commodities according to their unique release characteristics.