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兰索拉唑中有机溶剂残留量的测定

Determination of Residual Amount of Solvents in Lansoprazole

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【作者】 闫学斌李杰屈红丽姬小明张建业

【Author】 YAN Xue-Bin LI Jie QU Hong-Li JI Xiao-Ming ZHANG Jian-Ye(New Drug R&D Center,Department of Chemistry,Zhengzhou University,Zhengzhou 450052,P.R.China)

【机构】 郑州大学化学系新药研究开发中心郑州大学化学系新药研究开发中心 郑州市450052郑州市450052

【摘要】 文章建立了采用直接进样毛细管气相色谱法测定兰索拉唑中甲醇、乙醇、乙酸乙酯残留量的方法。色谱柱为HP-FFAP石英毛细管柱,采用程序升温,载气为氮气,检测器为FID,以二氧六环为溶剂。在上述色谱条件下,甲醇的线性范围为6—54mg/L,乙醇和乙酸乙酯的线性范围为10—90mg/L;平均加样回收率分别为99.36、101.26%和101.57%。本方法简便、专属性强、准确度高,可用于测定原料药中甲醇、乙醇、乙酸乙酯的残留量。

【Abstract】 A capillary gas chromatographic method with directly sampling was established to determination the residual amount of methanol,ethanol and ethyl acetate in lansoprazole.The analytical column was HP-FFAP capillary quartz column.The column temperature was programmed.The carrier gas was nitrogen.The detector was FID.Dioxane was selected as solvent.The linear range for methanol was 6—54mg/L,for ethanol and ethyl acetate both were 10—90mg/L.The average recovery of them was 99.36,101.26% and 101.57% respectively.In conclusion,the method was simple,rapidly,special,precision and it could be used for the determination of the residual amount of methanol,ethanol and ethyl acetate in drug substances.

  • 【文献出处】 光谱实验室 ,Chinese Journal of Spectroscopy Laboratory , 编辑部邮箱 ,2006年04期
  • 【分类号】TQ463.53
  • 【被引频次】2
  • 【下载频次】125
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