Author(s): Deepak Kumar Jain, Nitesh Jain, Rita Charde, and Nilesh Jain
Objective: A simple, precise, reliable, rapid, sensitive and validated RP-HPLC method has been developed to determine esomeprazole magnesium trihydrate (ESO) and naproxen (NAP) in synthetic mixture form. Materials and Methods: Chromatographic separation achieved isocratically on Phenomenex, Luna C18 column (5 μm, 150mm x 4.60mm) and acetonitrile: phosphate buffer (pH 7.0) in the ratio of 50:50 (v/v) as the mobile phase, at a flow rate of 0.5 ml/min. Detection was carried out at 300 nm. The retention times for NAP and ESO was found to be 2.67 ±0.014 and 5.65 ±0.09 min respectively. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the ICH guidelines. Results: The method was linear in the concentration range of 50-250 μg/ml for NAP and 2-10 μg/ml for ESO with correlation coefficient of 0.999 and 0.998 respectively. The mean recoveries obtained for NAP and ESO were 100.01% and 97.76 % respectively and RSD was less than 2. The correlation coefficients for all components are close to 1. Conclusions: Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of NAP and ESO.