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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
【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.
【Key words】 Capillary GC; Lansoprazole; Residual Solvent; Methanol; Ethanol; Ethyl Acetate.;
- 【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