顶空毛细管气相色谱法测定注射用血栓通(冻干)中有机溶剂残留量

Determination of Residual Solvents in the Injection Xushuantong (Freeze-dried) by Headspace Capillary Gas Chromatography

目的:建立顶空毛细管气相色谱法测定注射用血栓通(冻干)中的残留溶剂。方法:采用DB-624毛细管柱(30 m×0.25 mm×1.40μm),载气为氮气,FID检测器,程序升温,分流进样。结果:甲醇、乙醇、丙酮、正己烷、乙酸乙酯、正丁醇、苯、甲苯、二甲苯、1,2-二乙基苯和二乙烯苯在各自浓度范围内呈良好线性关系,精密度RSD%均小于2.8%,平均回收率分别为99.5%-104.1%(RSD%=1.0%-4%)。结论:本方法操作简便,结果准确可靠,适用于测定注射用血栓通(冻干)中有机溶剂的残留量。

ObjectiveTo establish Headspace Capillary Gas Chromatography method for the determination of the residual sol-vents in the injection Xushuantong（freeze-dried）. Methods： The Chromatographic conditions adopted were DB-624 capillary col-umn （30 m×0.25 mm×1.40μm）, with nitrogen as carrier gas and FID as detector.The temperature program and split injectionmode were used.Results： The calibration curves of Methanol, ethanol, acetone, n-heXane, ethyl acetate, n-butYl alcohol, ben-zene, toluene, XYlene, 1,2-2 eth Y1 benzene and dieth Y1 benzene showed good linear relationship. The precision was lowerthan 2.8%. The average recoveries was 99.5%-104.1%（RSD=l.O%-g%）. Conclusion： This method is accurate and reliable. Itcan be used for detection of the residual solvents in in the injection Xushuantong （freeze-dried）.