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GC法检测盐酸法舒地尔中有机溶剂残留量
引用本文:陈晶晶,雷咪,干伟,杨敏. GC法检测盐酸法舒地尔中有机溶剂残留量[J]. 中国药师, 2012, 15(3): 365-367
作者姓名:陈晶晶  雷咪  干伟  杨敏
作者单位:湖北中医药大学药学院 武汉430065
摘    要:目的:建立盐酸法舒地尔原料药中残留溶剂的气相色谱测定方法.方法:甲醇、二氯甲烷、叔丁基甲基醚(MTBE)采用顶空进样法进行检测,N,N-二甲基甲酰胺( DMF)采用直接进样法检测.结果:各组分完全分离,线性关系良好(r≥0.9996),平均回收率为89.6%~110.5%.结论:该方法适用于盐酸法舒地尔原料药中残留溶剂的测定,操作简便、结果准确、灵敏度高、重复性好.

关 键 词:气相色谱法  有机残留溶剂  自动顶空进样  直接进样
收稿时间:2011-09-27
修稿时间:2011-12-13

Determination of Residual Solvents in Fasudil Hydrochloride by GC
Chen Jingjing,Lei Mi,Gan Wei and Yang Min. Determination of Residual Solvents in Fasudil Hydrochloride by GC[J]. China Pharmacist, 2012, 15(3): 365-367
Authors:Chen Jingjing  Lei Mi  Gan Wei  Yang Min
Affiliation:College of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065;College of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065;College of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065;College of Pharmacy, Hubei University of Chinese Medicine, Wuhan 430065
Abstract:Objective:To establish a method to determine the residual solvents in fasudil hydrochloride.Method:Methanol, methylene chloride,methyl tert-butyl ether and dimethyl formamide were determined by head-space GC while DMF was determined by direct injection.Result:All the solvents could be completely separated with good linear relationships(r≥0.999 6).The average recovery was within the range of 89.6%-110.5%.Conclusion:The method can be used in the determination of the residual solvents in fasudil hydrochloride with the properties of simple,accurate,sensitive and repeatable.
Keywords:GC  Residual solvents  Head-space gas chromatography  Direct injection
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