韩薇,赵云丽,燕强勇,于治国,陈洁
HAN Wei1,ZHAO Yun-li1,YAN Qiang-yong1,YU Zhi-guo1,CHEN Jie2(1.School of Pharmacy

• 1:沈阳药科大学药学院
• 2:东北制药集团有限公司

摘要(Abstract)：

目的建立顶空气相色谱法测定埃索美拉唑钠中7种有机溶剂残留量的方法。方法采用DB-624(30 m×530μm,3μm)毛细管柱,经程序升温,氢火焰离子化检测器检测,载气为氮气。结果乙醇、丙酮、异丙醇、乙腈、二氯甲烷、甲基叔丁基醚及甲苯在考察范围内线性关系良好(r≥0.999 0),平均回收率为89.7%～104.6%,检测限分别为1.40、0.39、1.60、1.10、0.74、0.04、0.16 mg.L-1。结论本方法可用于埃索美拉唑钠中残留溶剂的检查。
Objective To develop a method for determination of seven kinds of residual solvents in esomeprazole sodium by headspace gas chromatography.Methods The residual solvents were separated on DB-624(30 m×530 μm,3 μm)capillary chromatographic column using temperature programming.Nitrogen gas was used as carrier gas with FID as detector.Results There was a good linear relationship in the experimental concentrations of ethanol,acetone,isopropanol,acetonitrile,dichloromethane,methyl tert-butyl ether,toluene(r≥0.999 0).The average recoveries were ranged from 89.7% to 104.6%.The limit of detection were 1.40,0.39,1.60,1.10,0.74,0.04 and 0.16 mg · L-1 respectively.Conclusions The method is sensitive,accurate and reproducible.It could be used for the detection of residual solvents in esomeprozole sodium.

关键词(KeyWords)： 埃索美拉唑钠;气相色谱法;残留溶剂
esomeprazole sodium;gas chromatography;residual solvent

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 韩薇,赵云丽,燕强勇,于治国,陈洁
HAN Wei1,ZHAO Yun-li1,YAN Qiang-yong1,YU Zhi-guo1,CHEN Jie2(1.School of Pharmacy

DOI: 10.14066/j.cnki.cn21-1349/r.2012.04.011

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