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

Abstract

Purpose: The goal of this 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. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing.

Methods: After testing solubility in the dissolution medium, surfactant concentration, rotation speed, dissolution medium pH, and apparatus type, the appropriate conditions were established.

Results: According to investigations, the optimal dissolution conditions were obtained utilising a USP apparatus II, 900 ml of 0.4 percent SLS medium in pH 4.5 acetate buffer, and a 75 rpm rotation speed.

Conclusion: This research shows how a discriminate dissolution method for Rivaroxaban, a BCS Class 2 medication with pH-independent solubility, was developed in a systematic manner. The dissolution method described here can be utilised as a quality control test for Rivaroxaban tablets, with a particular focus on batch to batch evaluations.