METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ESOMEPRAZOLE IN TABLET DOSAGE FORM BY RP-HPLC METHOD

Abstract

A simple, precise, rapid, and accurate RP-HPLC method has been developed to determine esomeprazole magnesium trihydrate using chromatographic separation isocratically on C18 column (5 μm, 150mm x 4.60mm) and acetonitrile: water (HPLC grade) in the ratio of 50:50 (v/v) as the mobile phase, at a flow rate of 1ml/min. Detection was carried out at 289 nm. The retention times was found to be 5.6, the method was linear in the concentration range of 10- 60μg/ml with R²=0.997 respectively. The proposed method is successfully applied for the determination of drugs in commercial tablet preparation. The results of the analysis have been validated statistically and by recovery studies.