GC法检测盐酸法舒地尔中有机溶剂残留量

Determination of Residual Solvents in Fasudil Hydrochloride by GC

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≥0.999 6),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。

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.