顶空气相色谱法测定可博利-2号口服液中氯仿残留量

Headspace Gas Chromatography Determination of Residual Chloroform in CPL-2 Oral Liquid

目的测定可博利2号口服液中有机溶剂氯仿残留量。方法采用顶空气相色谱法,电子捕获检测器(ECD):以GDX103(80～100目,2m玻柱)为固定相;柱温180℃;气化室温度250℃;检测器温度250℃;载气氮气。结果氯仿线性方程的相关系数r为0.9984,平均回收率为98.6%,RSD为0.66%(n=6);5批样品中氯仿残留量均符合规定。结论经方法学试验验证,该方法灵敏、准确,适用于可博利2号口服液中氯仿残留量的测定。

AIM To determine the contents of residual chloroform in CPL-2 Oral Liquid.METHODS GDX-103 column (2 m) and electron capture detector (ECD) was used for gas chromatography;The intial temperature was 180 ℃;The injection port and detector temperatures were 250 ℃;using nitrogen as the carrier gas.RESULTS The correlation rof chloroform was 0.9984.The recovery was 98.6% with RSD0.66%(n=6).The contents of residual chloroform in five bathes of samples were complied with the specification requirements.CONCLUSION After validation,the method was proved to be accurate sensitive and reliable.It was suitable to be adopted in the analysis of the tested the residual chloroform in the CPL-2 Oral Liquid.