兰索拉唑中有机溶剂残留量的测定

Determination of Residual Amount of Solvents in Lansoprazole

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。

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 then1 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.