GC-MS/MS法结合顶空进样测定原料药厄贝沙坦中N-亚硝基二甲胺(NDMA)与N-亚硝基二乙胺(NDEA)含量  

Determination of NDMA and NDEA in irbesartan by GCMSMS combined with headspace injection

作　　者：高洁 田菲菲 李月琪 范军 黄涛宏 GAO Jie;TIAN Feifei;LI Yueqi;FAN Jun;HUANG Taohong(Shimadzu(China)Co.,ltd,Beijing Branch,Beijing,100020,China;Shimadzu(China)Co.,ltd,Shanghai Branch,Shanghai,200233,China)

机构地区：[1]岛津企业管理(中国)有限公司北京分公司,北京100020 [2]岛津企业管理(中国)有限公司上海分公司,上海200233

出　　处：《环境化学》2021年第3期942-944,共3页Environmental Chemistry

摘　　要：本文使用三重四极杆气质联用仪GCMS-TQ8050结合顶空进样建立了一种快速检测原料药厄贝沙坦中N-亚硝基二甲胺(NDMA)与N-亚硝基二乙胺(NDEA)的方法.在浓度范围0.025—100μg两种物质均表现出良好线性,相关系数达到0.999以上,0.025μg标液信噪比(S;N)NDMA为11.7,NDEA为19.7.标准品连续进样6针,0.1μg与5μg峰面积RSD%分别小于3%与2%.0.1、0.2、5μg的加标平均回收率在96.2%—106.4%之间.该方法简单方便,可以较好的应用于厄贝沙坦原料药中NDMA和NDEA的含量的测定.A rapid method for the determination of N-nitrosodimethane(NDMA)and N-nitrosodiethylamine(NDEA)in irbesartan was established by triple quadrupole gas chromatography-mass spectrometry(GCMS-TQ8050)of Shimadzu company combined with headspace injection.In the concentration ranges of 0.025-100μg,the correlation coefficient were above 0.999,and the signal to noise ratio(S;N)of 0.25μg standard solution was 11.7 for NDMA and 19.7 for NDEA.The peak areas RSD%of 0.1μg and 5μg standard solutions were less than 3%and 2%,respectively.The average recoveries of 0.1,0.2,5μg were between 96.2%and 106.4%.The method is simple and convenient,and can be applied to the determination of NDMA and NDEA in irbesartan.

关 键 词：GCMS-TQ8050 N-亚硝基二甲胺(NDMA) N-亚硝基二乙胺(NDEA) 厄贝沙坦 

分 类 号：O657.63[理学—分析化学] TQ460.72[理学—化学]