王国成,陈莹,徐波
WANG Guo-cheng,CHEN Ying,XU Bo (Chem-Pharm R&D Institute

• 1:天津天士力集团化学制药研究所
• 2:天津天士力集团化学制药研究所
• 3:天津天士力集团化学制药研究所 天津300402
• 4:天津300402

摘要(Abstract)：

目的建立毛细管气相色谱法测定唑尼沙胺中的有机溶剂残留量。方法用DB-624毛细管气相色谱柱,FID检测器,以正丙醇为内标进行测定。结果甲醇、乙醇、乙酸乙酯、乙酸的线性范围分别为15.029~240.464 mg.L-1(r=0.999 9)、24.964~399.424 mg.L-1(r=1)、25.02~400.32 mg.L-1(r=0.999 9)、24.99~399.84 mg.L-1(r=0.999 9);甲醇、乙醇、乙酸乙酯、乙酸的平均回收率分别为99.5%、99.0%、98.9%、99.2%;RSD分别为1.2%、1.4%、1.2%、1.5%1(n=9)。结论方法简单、灵敏、准确、重现性好,适用于唑尼沙胺中的有机溶剂残留量的测定。
Objective To develop a gas chromatography method for the determination of residual organic solvents in zonisamid.Methods The samples were injected into DB-624 capillary column and analyzed with FID detector using n-propyl alcohol as the internal standard.Results The linear ranges of methanol,ethanol,ethyl acetate,acetic acid were 15.029-240.464 mg·L-1(r=0.999 9),24.964-399.424 mg·L-1(r=1),25.02-400.32 mg·L-1(r=0.999 9),24.99-399.84 mg·L-1(r=0.999 9),respectively.The recoveries were 99.5%,99.0%,98.9%,99.2%;RSD were 1.2%,1.4%,1.2%,1.5%(n=9),respectively.Conclusions The method is simple,accurate and sensitive with good reproducibility.It can be used for the determination of the residual organic solvents in zonisamide.

关键词(KeyWords)： 唑尼沙胺;毛细管气相色谱法;有机溶剂残留量
zonisamide;capillary gas chromatography;residual organic solvents

Abstract:

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基金项目(Foundation):

作者(Author): 王国成,陈莹,徐波
WANG Guo-cheng,CHEN Ying,XU Bo (Chem-Pharm R&D Institute

参考文献(References)：

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• [3]国家药典委员会.中华人民共和国药典[M].北京:化学工业出版社,2005.附录54-57.