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Determination of N-nitrosodimethylamine and N-nitrosodiethylamine in sartan preparations by gas chromatography-tandem mass spectrometry
Author(s): 
Pages: 582-585,589
Year: Issue:  9
Journal: Qilu Pharmaceutical Affairs

Keyword:  N-亚硝基二甲胺N-亚硝基二乙胺沙坦类制剂气相色谱-串联质谱法;
Abstract: 目的 建立检测沙坦类制剂中N-亚硝基二甲胺(NDMA)和N-亚硝基二乙胺(NDEA)含量的气相色谱-串联质谱法(GC-MS/MS).方法 以二氯甲烷为提取溶剂,经涡旋混匀、低温高速离心、微孔滤膜过滤后进行气相色谱-串联质谱分析.采用Agilent VF-WAX ms(30 m×0.25 mm,0.25μm)毛细管柱进行分离,程序升温,载气流速1 mL·min-1,不分流进样,进样量1μL.质谱分析采用EI源,多反应监测模式,外标法定量.结果 N-亚硝基二甲胺、N-亚硝基二乙胺的线性范围为0~250 ng·mL-1,方法的检出限N-亚硝基二甲胺为0.1 ng·mL-1、N-亚硝基二乙胺为0.08 ng·mL-1,定量限为N-亚硝基二甲胺为0.3 ng·mL-1、N-亚硝基二乙胺为0.2 ng·mL-1.N-亚硝基二甲胺平均回收率为86.9%~113.2%,RSD(相对标准偏差)为2.7%~7.4%;N-亚硝基二乙胺平均回收率为91.1%~105.3%,RSD为2.8%~8.4%.结论 本方法灵敏度高、专属性好、回收率高、线性范围宽,操作简便、快速,可用于沙坦类制剂的检验.
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