Abstract

METHOD DEVELOPMENT AND VALIDATION OF ASSAY AND DISSOLUTION FOR ETORICOXIB TABLETS

Vanita Baliram Jadhav*, Prachi Udapurkar, L. D. Hingane and Dr. Santosh R. Jain

ABSTRACT

A simple, accurate, precise, sensitive and reproducible reverse phase high performance liquid chromatography method has been developed for the quantitative determination of etoricoxib in pharmaceutical dosage forms. The assay was performed on inertsil ODS-4 column as stationary phase. The mobile phase containing 0.01M sodium perchlorate monohydrate and acetonitrile in the ratio of 48:52 v/v. The detection of analyte performed by using UV detector at wavelength maxima 235 nm. The column oven temperature was maintained at 30º C. Percentage recovery found within the limit ranges 98.9-99.5%. The calibration curve was linear over the concentration range of 70-130% and correlation coefficient was found to be 0.99. Peak purity had passed in the sample solution for all degradation conditions, no interference from placebo observed under stressed conditions. Sample solution was found to be stable at 10ºC for about 21 hours. In dissolution study the method was linear over the concentration range of 20-120% and correlation coefficient was found to be 0.99. Percentage recovery was found to be 99.3-100.8%. Filter equivalency was found within the limits for both standard solutions. The method was further validated with respect to linearity, accuracy, precision and robustness according to ICH guidelines. The method was statistically evaluated and can be applied for routine control analysis of etoricoxib in tablet formulations.

Keywords: Etoricoxib, filter equivalency, RP-HPLC, ICH, linearity, accuracy and precision.