DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHIC METHOD FOR NAPROXEN AND ESOMEPRAZOLE IN BINARY COMBINATION

The present study reports the development and validation of a simple, economic and sensitive HPLC method for the concurrent determination of naproxen and esomeprazole in pharmaceutical formulations. Isocratic chromatography was performed with C-18 column and mixture of phosphate buffer (pH 6.1) and acetonitrile in ratio of (40:60, v/v) at 1.5 mlmin(-1). The eluents were monitored at 302 nm using UV detector. The method was isocratic in the range of 9.38 to 300 mu gml(-1) for naproxen and 0.5 to 16 mu gml(-1) for esomeprazole. Validation of the method was performed by testing parameters like linearity, accuracy, precision, robustness, specificity, LOD and LOQ values. In the specificity the drugs were subjected to forced degradation studies like acidic, basic, oxidative and thermal stresses. Both the analytes were separated within three minutes. As the method separates the degradation products produced during forced degradation studies from the active analytes so it can be used not only for regular determination of naproxen and esomeprazole but also for their stability studies.