| HPLC法测定地夫可特的含量及有关物质 |
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| 引用本文： | 方滢芝,郑国钢.HPLC法测定地夫可特的含量及有关物质[J].药物分析杂志,2012(9):1669-1672. |
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| 作者姓名： | 方滢芝 郑国钢 |
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| 作者单位： | 浙江大学医学院附属邵逸夫医院;浙江省食品药品检验所 |
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| 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。
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| 关 键 词： | 肾上腺皮质激素类药 泼尼松龙衍生物 甾体抗炎药 地夫可特 噁唑物 溴羟物 脱溴物 水解物 杂质分析 高效液相色谱法 |
HPLC determination of deflazacort and its related substances |
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| FANG Ying-zhi,ZHENG Guo-gang.HPLC determination of deflazacort and its related substances[J].Chinese Journal of Pharmaceutical Analysis,2012(9):1669-1672. |
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| Authors: | FANG Ying-zhi ZHENG Guo-gang |
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| Institution: | 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) |
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| 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. |
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| Keywords: | adrenocortical hormone prednisolone derivatives steroidal anti-inflammatory drugs deflazacort oxazole bromine hydroxyl debromination hydrolysate impurity analysis HPLC |
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