期刊论文

中文

湖南文理学院学报(自然科学版)

1672-6146

2017

29

1

19-23

10.3969/j.issn.1672-6146.2017.01.005

湖南省教育厅科研项目(14A012).

本校为第一机构

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 li...