气相色谱法测定碳[^(13)C]-尿素中2种潜在基因毒性杂质  

Determination of Two Potentially Genotoxic Impurities in Urea C 13 by Gas Chromatography

作　　者：魏翠雯 张旭杰 陈凯 陈坚明 代德胜 WEI Cui-wen;ZHANG Xu-jie;CHEN Kai;CHEN Jian-ming;DAI De-sheng(Shenzhen Zhonghe Headway Bio-Sci&Tech Co.,Ltd.,Guangdong Shenzhen 518118,China)

机构地区：[1]深圳市中核海得威生物科技有限公司,广东深圳518118

出　　处：《广州化工》2023年第5期127-130,共4页GuangZhou Chemical Industry

摘　　要：建立了同时测定碳[^(13)C]-尿素中2种潜在基因毒性杂质的气相色谱法。采用DB-WAX UI毛细管色谱柱,通过FID检测器进行检测。结果表明,氨基甲酸甲酯和氨基甲酸乙酯的检测限分别为0.2μg/mL和0.1μg/mL;2种潜在基因毒性杂质在0.2~100μg/mL范围内,浓度与响应值呈显著线性关系;氨基甲酸甲酯回收率范围为90.6%~94.0%,氨基甲酸乙酯回收率范围为90.7%~93.6%。该方法操作简便、灵敏度高、准确性好。可有效控制碳[^(13)C]-尿素中的潜在基因毒性杂质。A method for simultaneous determination of two potentially genotoxic impurities in Urea C 13 was established.DB-wax UI capillary chromatographic column was used for detection through FID detector.The results showed that the detection limits of methyl carbamate and ethyl carbamate were 0.2μg/mL and 0.1μg/mL.The concentration of two potential genotoxic impurities was significantly linear with the response value in the range of 0.2~100μg/mL.The recoveries of methyl carbamate and ethyl carbamate were 90.6%~94.0%and 90.7%~93.6%.The method has the advantages of simple operation,high sensitivity and good accuracy.It can effectively control the potential genotoxic impurities in Urea C 13.

关 键 词：碳[^(13)C]-尿素 氨基甲酸甲酯 氨基甲酸乙酯 气相色谱 

分 类 号：R917[医药卫生—药物分析学]