Discriminatory Dissolution Method Development and Validation of Etoricoxib Tablets

Abstract

The availability of a discriminatory dissolution method for use in either quality control testing or product evaluation in quality by design trials is mandatory for products intended for the developed market. This study demonstrates the systematic development of a discriminatory dissolution method for etoricoxib, a BCS Class 2 drug exhibiting highly pHdependent solubility. The pH, speed, and apparatus were simultaneously optimized and tested for method variability, reproducibility, and robustness. The discriminative power of the developed method was suitably demonstrated.