顶空毛细管气相色谱法测定非那雄胺中有机溶剂的残留量

Determination of Residual Organic Solvents in Finasteride by Headspace Capillary Gas Chromatography

建立了顶空毛细管气相色谱法测定非那雄胺中二氯甲烷和氯仿两种有机溶剂残留量的方法,并讨论了平衡温度、平衡时间、盐效应对测定的影响。分析结果表明:该法可将两种残留有机溶剂完全分离,具有较好的线性(相关系数分别为0.999 7和0.999 8),检出限为3.2μg/L和0.094μg/L,测定结果的相对标准偏差分别为1.33%和0.89%,样品回收率分别为94%和96%。

A method for the determination of the contents of residual organic solvents such as chloroform and dichloromethane in finasteride by headspace capillary gas chromatography. The influencing factors such as equilibrium times, equilibrium temperature and salting-out were discussed. The experimental results showed that the peaks of two organic solvents were completely separated. The linearity in the detecting is good（0. 999 7 and 0. 999 8） with the detection limits of 3.2 μg/L and 0. 094μg/L. The RSDs were 1.33% and 0.89% .