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- W1990755599 abstract "The present work aim to develop a novel, sensitive and selective HPLC method for the determination of process impurities of Eprosartan mesylate Drug substance (EPM) and characterization of impurities using Mass Spectrometry and NMR. EPM and its impurities were determined by Agilent 1200 series HPLC with PDA detector. A phenomenex Gemini–C18 (250 mm × 4.6 mm × 5.0 μm) column was employed for the separation of impurities from EPM. The mobile phase consists of 10 Mm Ammonium acetate buffer (pH to 3.0) with acetic acid as solvent–A and Acetonitrile as solvent–B in gradient programme. All the impurities were well resolved from one another and EPM peak indicating the specificity of the proposed method to quantify EPM and its four impurities. Precision, method and intermediate precision for EPM was checked at specification level and the % RSD was found to be 0.36, 0.29 and 0.52. The developed HPLC method was found to be simple, sensitive, and selective. Detection limit for impurities was found to be as low as 0.01% and was found to have excellent resolution for four impurities indicating high sensitivity and selectivity of the validated method." @default.
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- W1990755599 date "2013-05-01" @default.
- W1990755599 modified "2023-10-14" @default.
- W1990755599 title "Determination and characterization of process impurities for Eprosartan mesylate" @default.
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- W1990755599 doi "https://doi.org/10.1016/j.jopr.2013.04.033" @default.
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