DEVELOPMENT AND VALIDATION OF ESOMEPRAZOLE AND NAPROXEN IN BULK AND TABLET DOSAGE FORM BY RP-HPLC METHOD

Abstract

A simple, rapid, reproducible, accurate and precise Reverse Phase HPLC method was developed for the quantitative
simultaneous estimation of Esomeprazole and Naproxen in combined tablet dosage form. Esomeprazole is used as antiulcerative and Naproxen has non steroidal anti-inflammatory activity. The chromatographic separation of both drugs was achieved with 250 x 4.6 mm, i.d 5 ?m C-18 column using acetonitrile:0.01 M potassium dihydrogen phosphate buffer (60:40 v/v) at the flow rate of 1.0 ml/min at 244.0 nm. The linearity range was found to be 2-30 ?g/ml for Esomeprazole and 5-100 ?g/ml for Naproxen. The coefficient of correlation for Esomeprazole and Naproxen was found to be 0.9993 and 0.9989 respectively. The percent recoveries obtained for Esomeprazole and Naproxen were found to be 99.86 and 99.72 respectively. The method was validated for linearity, range, precision, accuracy, specificity, selectivity, intermediate precision, ruggedness, robustness, stability and suitability.