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Determination of chloromethane and chloroethane in cefpodoxime proxetil by a gas chromatography-mass spectrometry method
Author(s): 
Pages: 377-379,408
Year: Issue:  6
Journal: Qilu Pharmaceutical Affairs

Keyword:  头孢泊肟酯氯甲烷氯乙烷基因毒性杂质气相色谱-质谱联用法;
Abstract: 目的 建立一种气相色谱-质谱联用法(GC-MS)对头孢泊肟酯原料药中的基因毒性杂质氯甲烷和氯乙烷进行定量检测.方法 采用MEGA-624MS色谱柱(60 m×0.25 mm,1.4μm),以电子轰击电离源为离子源,采集模式为选择离子监测(SIM).结果 氯甲烷在0.2525~1.263μg·mL-1内线性关系良好(r=0.9991),定量限为0.04040 ng·mL-1,检出限为0.01616 ng·mL-1;氯乙烷在0.6451~3.226μg·mL-1内线性关系良好(r=0.9997),定量限为0.1032 ng·mL-1,检出限为0.04129 ng·mL-1.氯甲烷和氯乙烷的回收率分别为100.8%、100.6%.结论 经方法学验证,该法可用于同时测定头孢泊肟酯中的氯甲烷和氯乙烷,能为质量控制提供参考.
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