电感耦合等离子体质谱法测定烟酰胺药物元素杂质  

Determination of elemental impurities of nicotinamide drug by inductively coupled plasma mass spectrometry

作　　者：朱俐 张才煜 赵瑜 许明哲 ZHU Li;ZHANG Caiyu;ZHAO Yu;XU Mingzhe(NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,National Institutes for Food and Drug Control,Beijing 102629)

机构地区：[1]国家药监局化学药品质量研究与评价重点实验室中国食品药品检定研究院,北京102629

出　　处：《分析试验室》2021年第12期1455-1460,共6页Chinese Journal of Analysis Laboratory

基　　金：国家药监局化学药品质量研究与评价重点实验室-药品中元素杂质与生产工艺相关性研究项目资助。

摘　　要：建立了烟酰胺药物中30种元素杂质的ICP-MS分析方法,并根据USP<233>进行了验证,在优化的实验条件下,本方法的检出限在4.0×10^(-4)~0.4μg/L之间,加标回收率在86.3%~116.0%之间,与ICP-OES检测结果基本一致。用所建立方法对烟酰胺以及稳定性样品进行了元素杂质检测,根据样品制备工艺初步判断元素杂质的来源。An inductively coupled plasma mass spectrometry(ICP-MS) based analysis method for 30 elemental impurities in niacinamide was established, and verified according to USP<233>. Under the optimized experimental conditions, the detection limits of the method were between 4.0×10^(-4)and 0.4 μg/L, and the recovery rates were between 86.3% and 116.0%. The results were basically consistent with the ICP-OES detection results. It was used to detect elemental impurities in nicotinamide and stability samples, and the source of elemental impurities were preliminarily determined according to the sample preparation process.

关 键 词：烟酰胺 电感耦合等离子体质谱 元素杂质 

分 类 号：R917[医药卫生—药物分析学]