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HPLC法测定地夫可特的含量及有关物质

HPLC determination of deflazacort and its related substances

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【作者】 方滢芝郑国钢

【Author】 FANG Ying-zhi1,ZHENG Guo-gang2(1.Affiliated Sir Run Run Shaw Hospital,Medicine College,Zhejiang University,Hangzhou 310016,China; 2.Zhejiang Institute for Food and Drug Control,Hangzhou 310004,China)

【机构】 浙江大学医学院附属邵逸夫医院浙江省食品药品检验所

【摘要】 目的:建立测定地夫可特含量及有关物质的高效液相色谱方法。方法:采用VP-ODS色谱柱(250 mm×4.6 mm,5μm),以水-乙腈(60∶40)为流动相,流速1.0 mL.min-1,检测波长244 nm。结果:在上述色谱条件下,各中间体及降解产物均可与地夫可特主峰良好分离。地夫可特与有关物质测定的线性范围分别为50.2~201.0"g.mL-1(r=0.9999)与2.0~15.1"g.mL-1(r=0.9993);方法的重复性与中间精密度RSD分别为0.43%和0.68%。结论:本文方法简便,可用于测定地夫可特的含量及有关物质。

【Abstract】 Objective:To establish a RP-HPLC method for content determination of deflazacort and its related substances.Methods:The separation was performed on a Shimadzu VP-ODS column(250 mm×4.6 mm,5 μm)with the mobile phase consisting of water-acetontrile(60∶ 40)at a flow rate of 1.0 mL·min-1,and the detection wavelength was set at 244 nm.Results:An excellent separation was achieved for deflazacort and its related substances.The linear ranges of deflazacort and its related substances were 50.2-201.0 g·mL-1(r=0.9999)and 2.0-15.1 g·mL-1(r=0.9993),respectively.The repeatability and intermediate precision were 0.43% and 0.68%.Conclusion:The method is simple and can be successfully applied in the determination of deflazacort and its related substances.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2012年09期
  • 【分类号】R927.2
  • 【下载频次】167
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