毛细管气相色谱法测定富马酸福莫特罗中的残留溶剂

Capillary gas chromatograghy for determination of residual solvents in formoterol fumarate

目的:建立毛细管气相色谱法检测富马酸福莫特罗中乙醇、异丙醇、二氯甲烷、乙酸乙酯和N,N-二甲基甲酰胺的方法。方法:采用DB-624毛细管色谱柱;柱温采用程序升温的方法;载气为氮气;FID检测器。结果:本色谱条件下,乙醇、异丙醇、二氯甲烷、乙酸乙酯和N,N-二甲基甲酰胺线性关系良好,相关系数均在0.999 6以上,平均回收率分别为101.0%、100.9%、102.8%、97.1%及100.5%。检出限分别为5、5、3、5及1.8μg/ml。结论:本法灵敏、准确,适用于富马酸福莫特罗残留溶剂的检测。

Objective： To establish a sample capillary gas chromatography method for the analysis of residual ethanol,isopropanol,dichlormethane ethyl acetate and N,N- dimethyl formamide in formoterol fumarate. Methods： The method included chromatogram systems,using DB- 624 capillary chromatograghic column（ 30 m × 0. 32 mm,1. 8 μm） with procedural column temperature control,was established. Nitrogen gas was used as carrier gas and FID as detector. Resuits： The correlation coefficient in ethanol,isopropanol,dichlormethane ethyl acetate and N,N- dimethyl formamide were all higher than 0. 999 6. The recoveries were101. 0%,100. 9%,102. 8%,97. 1%,100. 5%,respectively. The limit detection respectively were 5,5,3,5,1. 8 μg / ml. Cconclustion： This method is sensitive,accurate and can be used for quality control.