盐酸吉西他滨中残留溶剂的测定
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[摘要] 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(30 mm×0.53 mm，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7 min，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。
[关键词] 盐酸吉西他滨；气相色谱；残留溶剂
[中图分类号] R927.1 [文献标识码] B [文章编号] 2095-0616(2012)05-95-02
Determination of residual solvents in gemcitabine hydrochloride
LI Xiaobi1 WANG Chunling2
Jiangsu Hansoh Medicine Research Institute Co., Ltd., Lianyungang 222000, China
[Abstract] 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 ......
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