Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ETORICOXIB BY REVERSE PHASE ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY IN ORAL SOLID DOSAGE FORM

Ramya R.*, Gokulan. P. D., Senthilkumar K. L. and Radharavi K.

ABSTRACT

The purpose of the study was to develop a simple, specific, accurate and precise reverse phase ultra performance liquid chromatography method for the determination of etoricoxib in oral solid dosage form. Chromatographic determination was performed in a reverse base C18 column (3 mm X 50 mm; 2.1 microns) using a mixture of Buffer: Acetonitrile (500:500) as mobile phase and delivered at a flow rate of 0.5 ml/min. The UV Detector was 220nm. The Method was validated for accuracy, linearity, precision, specificity, robustness and system suitability according to ICH guideline. The Result obtain was linearity (r2 >0.99), precision (RSD = 0.63% intraassay; RSD = 0.51% intraassay), accuracy (recovery = 99.99 and RSD = 0.98%), system suitability (RSD of Area = 0.15%) and specificity (Response of placebo solution 0% and Response of sample solution 101.86%). All statistical data proves validity of the method and can be used for routine analysis of pharmaceutical formulation.

Keywords: Reverse phase ultra performance liquid Chromatography, 220nm, Method development, Validation, Etoricoxib and Acetonitrile.