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卡培他滨中有机残留溶剂的检测
引用本文:益磊,单静静,周至美,耿武松,孟祥松,蒋磊.卡培他滨中有机残留溶剂的检测[J].中南药学,2013,11(1):60-62.
作者姓名:益磊  单静静  周至美  耿武松  孟祥松  蒋磊
作者单位:1. 亳州市食品药品检验所,安徽亳州,236800
2. 安徽恒星制药有限公司,合肥,230000
摘    要:目的建立气相色谱法测定卡培他滨原料药中二氯甲烷、乙醇、甲醇和乙酸乙酯4种有机溶剂。方法采用DB-624毛细管柱,FID检测器,以DMSO为溶剂。结果各有机溶剂的平均加样回收率为93.7%~97.6%,RSD为2.5%~3.7%。结论该方法稳定准确,可用于卡培他滨中有机溶剂残留的检测。

关 键 词:卡培他滨  有机溶剂残留  气相色谱  检测

Determination of residual organic solvents in capecitabine
YI Lei , SHAN Jing-jing , ZHOU Zhi-mei , GENG Wu-song , MENG Xiang-song , JIANG Lei.Determination of residual organic solvents in capecitabine[J].Central South Pharmacy,2013,11(1):60-62.
Authors:YI Lei  SHAN Jing-jing  ZHOU Zhi-mei  GENG Wu-song  MENG Xiang-song  JIANG Lei
Affiliation:1(1.Bozhou Institute for Food and Drug Control,Bozhou Anhui 236800;2.Anhui Healstar Pharmaceutical Co.Ltd,Hefei 230000)
Abstract:Objective To establish a GC method for the determination of residual organic volatitl solvents-dichloromethane,methanol,ethyl acetate and sthanolin tiotropium bromide in capecitabine.Methods A DB-624 capillary column was used,with FID as the detector and DMSO as the solvent.Results The average recoveries were 93.7%-97.6%,with RSDs of 2.5%-3.7%.Conclusion The method is stable and accurate,and can apply to the determination of the 4 residual organic solvents in capecitabine.
Keywords:capecitabine  residual organic solvent  GC  determination
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