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曲司氯铵中有机溶剂残留的顶空毛细管气相色谱法测定

Determination of Residual Organic Solvents in Trospium Chloride by Headspace Capillary Gas Chromatography

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【作者】 杨新颖宋伟国侯准桑立红方浩

【Author】 YANG Xinying;SONG Weiguo;HOU Zhun;SANG Lihong;FANG Hao;School of Pharmacy,Shandong University;Shouguang Fukang Pharmaceutical Co.,Ltd;

【机构】 山东大学药学院寿光富康制药有限公司

【摘要】 建立了顶空毛细管气相色谱法测定曲司氯铵中可能残留的乙醚、丙酮、甲醇、二氯甲烷、乙醇、三氯甲烷和二甲基甲酰胺。以二甲亚砜为溶剂,采用AC20毛细管柱和氧火焰离了化检测器。上述7种有机溶剂分别在50~1000、50~1000、30~600、6~120、50~1000、0.6~12和8.8~176μg/ml浓度范围内线性关系良好,回收率分别为98.1%、100.9%、97.5%、99.2%、98.6%、95.2%和94.2%,RSD不大于3.4%。

【Abstract】 A static headspace capillary gas chromatography method was established for the determination of seven residual solvents,such as ether,acetone,methanol,dichloromethane,ethanol,chloroform and DMF,in trospium chloride.An AC20 capillary column and flame ionization detector were used with DMSO as the solvent.Their calibration curves were linear in the concentration ranges of 50- 1 000,50- 1 000,30- 600,6- 120,50- 1 000,0.6- 12 and 8.8-176 μg/ml,respectively.Their recoveries were 98.1%,100.9%,97.5%,99.2%,98.6%,95.2%and 94.2%,with RSDs no more than 3.4%.

  • 【文献出处】 中国医药工业杂志 ,Chinese Journal of Pharmaceuticals , 编辑部邮箱 ,2014年02期
  • 【分类号】TQ460.72;O657.71
  • 【被引频次】2
  • 【下载频次】96
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