Identification and quantification of impurities in amlodipine besylate tablets
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    Abstract:

    Objective:To identify and determine the impurities in amlodipine beslyate tablets. Methods:The main impurities in amlodipine beslyate tablets were identified with LC-MS,NMR and chromatographic methods. Then the main impurities were determined with C18 column as stationary phase and buffer (pH 3.0)-methanol-acetontrile 50∶35∶15 as mobile phase. Results:The main impurity in amlodipine beslyate tablets was proved to be the dehydration product of amlodipine (Impurity A,IM A). IM A could be completely separated with the established method. It was a linear correlation between the area and the concentration in the range of 0.5~10.0 μg/ml. The Limit of Quantification of the method was 10 ng/ml,recovery was 98.2%(n = 9) and the RSD of the method was 0.2%(n = 6). Conclusion:The main impurity in amlodipine beslyate tablets was IM A. The established method is accurate,simple and is suitable for determination of IM A in amlodipine beslyate tablets.

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Zhao Xia, Li Bo, Chen Bowei, Wang Suilou. Identification and quantification of impurities in amlodipine besylate tablets[J].,2013,(9):1314-1317.

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History
  • Received:March 29,2013
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  • Online: September 18,2013
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