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Stability indicating method validation for the estimation of Esomeprazole Magnesium Capsules and determination of Potential Impurities by RP-HPLC

A novel reverse phase high performance liquid chromatographic method was developed and validated for the determination of Esomeprazole capsules. The method was found to be simple, precise and accurate. The method involved a mobile phase comprising of Glycine(0.05M) buffer (PH 9+0.05) and Acetonitrile (70:30v/v) and a X-BRIDGE- 250*4.6, 5μ, C8 (4.6 X 250, 5μ) column. The flow rate was maintained at 1.8 ml/min and the detection was done at 305 nm. The retention time was found to be 3.9 mins. The method was found to be linear in the concentration range of 30- 180ppm. The analytical method was validated according to ICH guidelines (ICH Q2b). The correlation coefficient (r2) was found to be 0.9996, % recovery was 98.7-100.8% and %RSD for precision on replicate injection was 0.6 and intermediate precision for intraday precision at condition-I and II was 0.1, 0.34 and interday precision was 0.13% respectively. The precision study was precise, robust, and repeatable. LOD value was and LOQ value was. The developed method was validated by performing validation parameters like linearity, accuracy, precision, specificity and robustness. The method was found to be reliable for the determination of Esomeprazole in pharmaceutical dosage forms.

Author(s): K. S. Nataraj, M. Sushma Divya Tejaswini, K. Chaitanya, N. Sayeed, N. Roshna, I. Manasa

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