Determination of different manufacturers of Clopidogrel Hydrogen Sulfate and Its related Substances by HPLC
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Department of Pharmaceutics,Changhai Hospital,Second Military Medical University,Department of Pharmaceutics,Changhai Hospital,Second Military Medical University,,Department of Pharmaceutics,Changhai Hospital,Second Military Medical University,Department of Pharmaceutics,Changhai Hospital,Second Military Medical University,Department of Pharmaceutics,Changhai Hospital,Second Military Medical University,Department of Pharmaceutics,Changhai Hospital,Second Military Medical University

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    Abstract:

    Objective A HPLC method for quantitative determination of clopidogrel hydrogen sulfate and its related substances was established .We also compared the content of effective components and impurity of clopidogrel tablets from three manufactures. Method an UL-TRON ES-OVM column (5μ m, 4.6mm × 150 mm) was used, The mobile phase consisted of a mixture of acetonitrile and 0.01M potassium dihydrogen phosphate solution (20:80). The flow-rate was 1ml/min, the column temperature 17℃, the UV detection was performed at 220 nm. Result Clopidogrel Hydrogen Sulfate and its related substances in 50 mg/L~117 mg/L and 1.52mg/L~30.04 mg/L were respectively in good linear relationship (correlation coefficient r = 0.9998). Conclusion The method is accurate and has good specificity. It can be used for the determination of Clopidogrel Hydrogen Sulfate and its related substances.

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History
  • Received:March 20,2014
  • Revised:May 26,2014
  • Adopted:June 19,2014
  • Online: September 22,2014
  • Published:
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