DEVELOPMENT AND VALIDATION OF METHOD FOR DETERMINATION OF ESOMEPRAZOLE BY HPLC

Abstract

A simple, selective and rapid reversed phase high performance liquid chromatographic (RPHPLC) method for the analysis of esomeprazole has been developed and validated. The separation was achieved from HPLC Column (Prevail C8, 5µ, 4.6 mm x 150 mm) with a mobile phase consisting of HPLC grade acetonitrile and phosphate buffer solution (35:65) at a flow rate of 1ml/min with UV detection at 280nm. The method was specific and it was observed that no interference with diluents. The proposed method was accurate with 99.12% recovery for esomeprazole and precise (%RSD of area of system precision, % RSD of assay of method precision and Intermediate precision were found to be 0.09%, 0.21% and 0.43% respectively). From the linearity study the correlation coefficient is found to be 1.0000, which indicated that the method was linear over 10% to 150% range. The method was found robust for possible changes. Therefore, this method can be used as a more convenient and efficient option for the analysis of esomeprazole to establish the quality of the drug substance during routine analysis with consistent and reproducible results.