Simultaneous Estimation of Naproxen and Esomeprazole by RP-HPLC and its Validation

A simple, accurate, economical and precise reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous determination of Naproxen and Esomeprazole. The separation was achieved on Agilent CN column (250 x 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of Acetonitrile: K₂HPO₄: KH₂PO₄ (60: 20: 20) in an isocratic mode, at a flow rate of 2 ml/min. The detection was monitored at 257 nm. The retention time of Naproxen and Esomeprazole were 2.22 min and 3.24 min respectively. The linearity was found to be in the range of 150–350 μg/ml and 6–14 μg/ml for Naproxen and Esomeprazole respectively with correlation coefficient of 0.999. The proposed method was validated according to ICH guidelines for parameters like linearity, accuracy, precision and specificity. All validation parameters were within the acceptable range. The developed method was successfully applied for the estimation of Naproxen and Esomeprazole in pure and pharmaceutical dosage form.