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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
引用本文:高洁,田菲菲,李月琪,范军,黄涛宏.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[J].环境化学,2021,40(3):942-944.
作者姓名:高洁  田菲菲  李月琪  范军  黄涛宏
作者单位:岛津企业管理(中国)有限公司北京分公司,北京,100020;岛津企业管理(中国)有限公司上海分公司,上海,200233
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.

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

Determination of NDMA and NDEA in irbesartan by GCMSMS combined with headspace injection
GAO Jie,TIAN Feifei,LI Yueqi,FAN Jun,HUANG Taohong.Determination of NDMA and NDEA in irbesartan by GCMSMS combined with headspace injection[J].Environmental Chemistry,2021,40(3):942-944.
Authors:GAO Jie  TIAN Feifei  LI Yueqi  FAN Jun  HUANG Taohong
Institution:(Shimadzu(China)Co.,ltd,Beijing Branch,Beijing,100020,China;Shimadzu(China)Co.,ltd,Shanghai Branch,Shanghai,200233,China)
Abstract: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.
Keywords:GCMS-TQ8050  N-nitrosodimethane(NDMA)  N-nitrosodiethylamine(NDEA)  Irbesartan
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