毛细管气相色谱法测定盐酸帕罗西汀中残留溶剂

Capillary gas chromatography for determining residual solvents in paroxetine hydrochloride

目的:建立顶空进样-毛细管气相色谱法,检测盐酸帕罗西汀中甲醇、乙醇、异丙醇、二氯甲烷与甲苯等残留溶剂的含量。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,甲醇、乙醇、异丙醇、二氯甲烷与甲苯线性关系良好,相关系数均在0.999 3以上,平均回收率分别为95.1%、103.5%、97.8%、102.6%和100.9%。检出限分别为1.5、2.5、2.5、0.3和0.4μg/ml。结论:本方法灵敏、准确,适用于盐酸帕罗西汀残留溶剂的检测。

OBJECTIVE To establish a sample capillary gas chromatography method with headspace injector for the analyzing residual methanol, ethanol, isopropanol, dichlormethane and toluene in paroxetine hydrochloride. METHODS The method included chromatogram systems, using DB - 624 capillary chromatographic column （30 m× 0.32 mm, 1.8 μm） with procedural column temperature control. Nitrogen gas was used as carrier gas and FID as detector. RESUITS The correlation coefficient in methanol, ethanol, isopropanol, dichlormethane and toluene was all higher than 0. 999 3. The recoveries were 95.1% , 103.5 %, 97.8%, 102.6%, 100.9% ,respectively. The limit detection respectively were 1.5,2.5,2.5,0.3,0.4 μg/ml. CONCLUSION This method is sensitive, accurate and can be used for quality control.