盐酸吉西他滨中残留溶剂的测定

目的对盐酸吉西他滨中的残留溶剂进行测定。方法采用顶空气相色谱法,DB-WAX石英毛细管柱(30mm×0.53mm,1.0μm),进样口温度为150℃;氢火焰离子化检测器,载气为氮气,检测器温度为240℃,柱初温40℃维持7min,以10℃/min升温速率升至120℃。结果被测溶剂均能得到很好的分离,每一个溶剂的峰面积与浓度在一定的范围内均呈良好的线性关系。结论该方法作为盐酸吉西他滨中残留溶剂的检测是准确、可靠的。

Determination of residual solvents in gemcitabine hydrochloride

Objective To establish a method for detection of residual solvents in gemcitabine hydrochloride.Methods The residual solvents in gemcitabine hydrochloride was determined by headspace GC with DB-WAX capillary column(30 mm×0.53 mm,1μm) with FID detector and nitrogen as the carries gas.The injector temperature was 150℃,the detector temperature was 240℃,the column temperature rosed by program,the initial temperature was 40℃ and maintained for 7 min,rosed to 120 ℃ with a rate of 10 ℃ /min.Results The solvents could be completely separated,and the calibration curves of each solvent had good linear relationship within a certain range.Conclusion The method is proved accurate and reliable,it can be used for the determination of residual solvents in gemcitabine hydrochloride.