节点文献

雌二醇中残留溶剂测定方法的建立

Establishment of a Method for Determination of Residual Solvent in Estradiol

  • 推荐 CAJ下载
  • PDF下载
  • 不支持迅雷等下载工具,请取消加速工具后下载。

【作者】 高慧如彭飞城谭英李昭盛忻石笑弋

【Author】 GAO Huiru;PENG Feicheng;TAN Ying;LI Zhao;SHENG Xin;SHI Xiaoyi;Hunan Institute for Drug ControL and Testing;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research;

【通讯作者】 石笑弋;

【机构】 湖南省药品检验检测研究院国家药品监督管理局药用辅料工程技术研究重点实验室

【摘要】 建立顶空气相色谱法,同时测定雌二醇中的残留溶剂甲醇和乙醇。采用以6%氰丙基和94%二甲基聚硅氧烷为固定相的毛细管柱作为色谱柱,用氢火焰离子化检测器检测。方法学验证结果表明:甲醇质量浓度为2.01~20.1μg/m L时残留溶剂线性关系良好(r=0.999 8),乙醇质量浓度为2.00~24.0μg/m L时残留溶剂线性关系良好(r=0.999 8);甲醇回收率分别为106.9%、102.2%、100.8%,乙醇回收率为104.3%、103.8%、105.9%。该方法专属性强、灵敏度高、准确性好,可用于雌二醇中残留溶剂的测定。

【Abstract】 The paper established a headspace gas chromatography method and simultaneously determined the residual solvents methanol and ethanol in estradiol. The paper uses a capillary column with 6% cyanopropyl and 94% dimethylpolysiloxane as stationary phases as the chromatographic column, and is detected by a hydrogen flame ionization detector. The methodological validation results indicate that methanol ranges from 2.01 to 20.1 μ. The linear relationship is good within the range of g/mL(r=0.999 8), and ethanol ranges from 2.00 to 24.0 μ. The linear relationship is good within the range of g/mL(r=0.999 8); The recovery rates of methanol are 106.9%, 102.2%, and 100.8%, respectively, while the recovery rates of ethanol are 104.3%, 103.8%, and105.9%. This method has strong specificity, high sensitivity, and good accuracy, and can be used for the determination of residual solvents in estradiol.

【关键词】 雌二醇残留溶剂气相色谱
【Key words】 estradiolresidual solventgas chromatography
  • 【文献出处】 工业微生物 ,Industrial Microbiology , 编辑部邮箱 ,2024年02期
  • 【分类号】O657.7;TQ460.72
  • 【下载频次】91
节点文献中: