Rapid Liquid Chromatographic Method for Quantification and Dissolution of Naproxen and Esomeprazole in Tablet Dosage Form
Abstract
In the present study, a new reverse phase high performance liquid chromatography method for the quantification and dissolution determination of naproxen and esomeprazole in tablet formulation has been developed and validated. Naproxen and esomeprazole in samples were analyzed by using the reversed-phase column Phenemonex Luna C18 (150x4.6 mm, 5µm) and the mobile phase consisting of pH:7.0 phosphate buffer and acetonitrile (50:50, v:v) at the constant flow rate (0.5ml/min) with a UV detection at 300 nm. In the assay validation a good linear relationship was observed for naproxen and esomeprazole in the concentration ranges of 0.1-0.7 mg/ml and 0.004-0.028 mg/ml respectively. The correlation coefficient for naproxen was found to be 1.0000 and that for esomeprazole was 0.9996. In the dissolution validation a good linear relationship was observed for naproxen and esomeprazole in the concentration ranges of 0.05-0.35 mg/ml and 0.002-0.014 mg/ml respectively. The correlation coefficient for naproxen was found to be 1.0000 and that for esomeprazole was 0.9996. The liquid chromatographic method can be applied to the routine quality control analysis of determination of naproxen and esomeprazole in tablet dosage form.
