Determination of Etoricoxib in Bulk Drug, Dosage Form and Human Plasma by UV- Spectrophotometry

Abstract

A simple, rapid, precise spectrophotometric method for estimation of etoricoxib in bulk drug, dosage form and human plasma was developed. Sample preparation for the developed method employs 90% methanolic sodium hydroxide (0.1 M) as the solvent system for analyzing bulk drug and dosage form, while precipitation using acetonitrile (direct procedure) and liquid-liquid extraction with ethyl acetate (indirect procedure) was utilized for determination in human plasma samples. All samples were analyzed spectrophotometrically at 280 nm. For analysis of dosage form the method was found to be linear in the range of 3- 60 μg/mL (r² = 0.9997 and 0.9998); for estimation of human plasma samples the method was found to be linear in the range of 0.1-20 μg/mL (r² = 0.9998 and 0.9994 respectively for direct and indirect method). Results of sample analysis of dosage form showed variability in 98.60-102.48% concentration range and the standard deviation was found to be between 0.0563-0.1291 while the variability of results for analyzing plasma samples was found to be between 98.8-101.11% and 91.32-99.61% concentration range for direct and indirect method and the standard deviation was found to be between 0.015-0.072 and 0.04-0.08, respectively. The limit of detection for direct procedure and indirect procedure was found to be 0.0194 and 0.175 μg/mL respectively. The method was validated according to ICH guidelines and values for accuracy, precision, specificity and robustness were found to be within the acceptable limits. The method was successfully employed for determination of concentration of etoricoxib in bulk drug, dosage form and for in vitro estimation of concentration of etoricoxib in human plasma.