埃索美拉唑钠原料药残留溶剂的测定  

Determination of residual solvents for drug substances of Esomeprazole Sodium

作　　者：李佑达 张玲[1] 谭淑珍[1] 王述维 Li Youda;Zhang Ling;Tan Shuzhen;Wang Shuwei(College of Chemistry and Biological Engineering, Changsha University of Science and Technology, Changsha 410114, China;Changsha RHON Pharmaceutical Science and Technology Co. Ltd, Changsha 410007, China)

机构地区：[1]长沙理工大学化学与生物工程学院,湖南长沙410114 [2]长沙市如虹医药科技股份有限公司,湖南长沙410007

出　　处：《湖南文理学院学报（自然科学版）》2017年第1期19-23,共5页Journal of Hunan University of Arts and Science(Science and Technology)

基　　金：湖南省教育厅科研项目(14A012)

摘　　要：利用顶空气相色谱法测定了埃索美拉唑钠原料药中6种有机溶剂的含量。在该色谱条件下,6种有机溶剂均能彼此完全分离,峰面积与浓度呈现良好线性关系,相关系数均大于0.990。检出限(3S/N)分别为1.52、7.37、2.54、0.17、4.37、0.67μg/m L,定量限(10S/N)分别为2.83、10.92、7.93、0.34、9.83、2.69μg/m L。平均回收率均在98.74%~108.59%范围内。该方法适用于实际样品的残留溶剂测定。A gas chromatography(GC)method is developed for determination of six residual solvents includingacetone,dichloromethane,ethyl acetate,n-heptane,methyl isobutyl ketone and toluene in the drug substance ofEsomeprazole Sodium.The six residual solvents are separated completely under the given chromatogram system.The calibration curve of each solvent shows that it is a good linear relationship,and the correlation coefficients R ofeach solvent is more than0.990;the limits of detection(3S/N)are listed as1.52,7.37,2.54,0.17,4.37and0.67μg/mL,and the limits of quantitation(10S/N)are2.83,10.92,7.93,0.34,9.83,2.69μg/mL,respectively;the meanrecoveries of each solvent were all in the range of98.74%～108.59%.The method is suitable for determination ofresidual solvents in practical samples.

关 键 词：气相色谱法 顶空进样 埃索美拉唑钠 残留溶剂 

分 类 号：O657.71[理学—分析化学]