Development of a Discriminatory Drug Dissolution Method for Estimation of Rivaroxaban from Rivaroxaban Tablets

Abstract

Purpose: The objective of the present study is to develop discriminatory dissolution method to be used as a release parameter for testing and evaluating product performance by using quality by design trials intended for regulated markets. Methods: The appropriate conditions were determined after testing solubility in dissolution medium, surfactant concentration, rotation speed, pH of the dissolution medium, apparatus type. Results: Based on studies, the best dissolution conditions were achieved using a USP apparatus II, 900 ml of medium of 0.4% SLS in pH 4.5 acetate buffer at a rotation speed of 75 rpm. Conclusion: This study demonstrates the systematic development of a discriminatory dissolution method for Rivaroxaban, a BCS Class 2 drug exhibiting pH-independent solubility. The dissolution method presented here can be used as a quality control test for Rivaroxaban tablet with special emphasis to understand in a batch to batch evaluation.