DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF ESOMEPRAZOLE SODIUM BY HPLC

Abstract

A very simple, accurate, specific, precise and rapid reverse phase high performance liquid chromatography technique has been built up as well as validated to determine the Esomeprazole Sodium. The method is applicable for the quantitative analysis of the drug substance. Chromatographic separation was achieved on a Supelco 250-mm, 4.6-mm, and 5-$\mu$m C-18 analytical column with a mixture of Buffer and Acetonitrile at a volume ratio of 55:45 (v/v) as mobile phase at a flow rate of 1.0 mL /min. The molecule eluted within a short runtime (within 7.0 min). The eluted compound was monitored at a detector wavelength of 302 nm and the column oven temperature was maintained at 25 °C. The developed method was validated according to ICH guidelines. The high recovery and low relative standard deviation confirm the suitability of the method for determination of Esomeprazole Sodium. The repeatability and intermediate precision, expressed by the % RSD, were less than 2%. Accuracy (% recovery: 98.00- 102.00%) was found to satisfactory. The method was validated by determining its accuracy, precision, system suitability, linearity and robustness. Validation studies reveal that the method is simple, specific, rapid, reproducible, precise and accurate, which is useful for the routine determination of Esomeprazole Sodium.