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顶空气相色谱法测定水飞蓟宾葡甲胺中有机溶剂的残留量
引用本文:刘翔,孟荔枝.顶空气相色谱法测定水飞蓟宾葡甲胺中有机溶剂的残留量[J].中国药事,2011,25(4):370-372.
作者姓名:刘翔  孟荔枝
作者单位:江苏省镇江药品检验所,镇江,212003
摘    要:目的测定水飞蓟宾葡甲胺中有机溶剂乙醇和乙酸乙酯的残留量。方法采用顶空气相色谱法,HP-5毛细管柱;FID检测器,温度:200℃,柱温:65℃,进样口温度:150℃,氮气流速:1mL.min-1,氢气流速:40mL.min-1,空气流速:450mL.min-1,分流比2∶1,平衡温度:80℃,平衡时间:30min;以氮气为载气。结果乙醇和乙酸乙酯的检测限分别为:0.72μg.mL-1和0.036μg.mL-1;线性关系良好;平均加样回收率分别为96.77%和101.98%。结论本试验建立的方法准确、灵敏,为水飞蓟宾葡甲胺质量的控制提供了试验依据。

关 键 词:水飞蓟宾葡甲胺  有机溶剂残留量  顶空进样毛细管气相色谱法

Determination of Residual Organic Solvent in Silybin-N-Meglumine by Headspace GC
Liu Xiang,Meng Lizhi.Determination of Residual Organic Solvent in Silybin-N-Meglumine by Headspace GC[J].Chinese Pharmaceutical Affairs,2011,25(4):370-372.
Authors:Liu Xiang  Meng Lizhi
Institution:Liu Xiang and Meng Lizhi(Zhenjiang Institute for Drug Control,Jiangsu Province,Zhenjiang 212003)
Abstract:Objective To determine the contents of residual organic solvents: ethanol and ethyl acetate.Methods Headspace GC method with FID detector for deternimation of the contents of residual organic solvents was established.An HP-5 column was used with procedural column temperature control.Nitrogen gas was used as carrier gas.Results The detection limits of ethanol and ethyl acetate were 0.72μg·mL-1 and 0.036μg·mL-1,respectively.The calibration curves were linear.The average recoveries were 96.77% and 101.98%,respectively.Conclusion The method is accurate and sensitive.It provides the experimental basis for the quality control of Silybin-N-Meglumine.
Keywords:Silybin-N-Meglumine  residual organic solvents  Headspace GC  
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