A Validated Stability Indicating Ultra performance Liquid Chromatographic method for Determination of Impurities in Esomeprazole Magnesium Gastro Resistant Tablets
A novel gradient reversed-phase ultra performance liquid chromatographic method has been developed for quantitative determination of Esomeprazole magnesium and its seven impurities in pharmaceutical dosage forms. Chromatographic separation has been achieved on an Acquity BEH C18, 5 x 2.1mm, 1.7μm with buffered mobile phase consisting solvent A (.4 molar (M) glycine (pH 9.) buffer) and solvent B (mixture of acetonitrile and Milli-Q water in the ratio 9: 1 (v/v); respectively) delivered at flow rate of .21 mL min−1 and the detection wavelength 35 nm. Resolution of Esomeprazole magnesium and all the seven potential impurities has been achieved greater than 2. Highlights: The Fig. 2 was redrawn. The manuscripts was checked for English (US) language and corrected. No any technical changes were made.
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