ICP-MS测定化药左羟丙哌嗪胶囊中二氧化钛的不确定度分析与评定  

Assessment and Analysis of Uncertainty in ICP-MS Measurement of Titanium Dioxide in the Levodropropizine Capsule

作　　者：石笑弋 李昭 刘轶 李琦 谭英 兰文 郑金凤 刘雁鸣 吴碧涛 Shi Xiaoyi;Li Zhao;Liu Yi;Li Qi;Tan Ying;Lan Wen;Zheng Jinfeng;Liu Yangming;Wu Bitao(Hunan Institute for Drug ControL and Testing,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China;Hunan Engineering&Technology Research Center for Quality Evaluation of Pharmaceutical,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001 [3]湖南省药品质量评价工程技术研究中心,湖南长沙410001

出　　处：《广东化工》2024年第15期146-148,共3页Guangdong Chemical Industry

摘　　要：目的:采用电感耦合等离子体质谱法(ICP-MS)对化学药品左羟丙哌嗪胶囊中空胶囊的二氧化钛含量开展不确定度来源分析及评定。方法:依据CNAS-GL006-2019《化学分析中不确定度的评估指南》及JJF 1059.1-2012《测量不确定度评定与表示》的要求和方法,对所建立的方法进行影响不确定度来源分析,并对各不确定度分量进行评定和合成,计算扩展不确定度。结果:当称样量为0.25g时,空胶囊中二氧化钛的含量为1.67%,扩展的不确定度为0.0097%,k=2。结论:分析后确定,对不确定度因素贡献最大的主要来源有:标准物质溶液的配制,相对不确定度为0.92%,其他工作环节引入的不确定度可以忽略。Objective:This study investigates the sources of uncertainty in the content of titanium dioxide in empty capsules of levodropropizine capsule using inductively coupled plasma mass spectrometry(ICP-MS).According to CNAS-GL006-2019 Guidance on quantifying uncertainty in chemical analysis and JJF 1059.1-2012 Evaluation and expression of uncertainty in measurement,Source of influence uncertainty analysis of the established method,the uncertainty components were evaluated and synthesized,and the extended uncertainty was calculated.RESULTS For a sample weight of 0.25 g,the content of titanium dioxide in empty capsules was 1.67%,and the expanded uncertainty was 0.0097%,k=2.Conclusion:Through analysis,the main sources of the most uncertainty were determined as follows:standard substance solution is prepared with a relative uncertainty of 0.92%,and the uncertainty introduced in other work links can be ignored.

关 键 词：左羟丙哌嗪胶囊 空心胶囊 电感耦合等离子体原子发射光谱 二氧化钛 不确定度评定 

分 类 号：R927.2[医药卫生—药学] O657.63[理学—分析化学]