ICP-MS法测定盐酸雷尼替丁胶囊空胶囊中二氧化钛含量的不确定度评定  

Evaluation of Uncertainty in Determination of Titanium Dioxide Content in Ranitidine Hydrochloride Hollow Capsules by ICP-MS

作　　者：刘轶 李昭 李琦 兰文 盛忻 石笑弋 LIU Yi;LI Zhao;LI Qi;LAN Wen;SHENG Xin;SHI Xiaoyi(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：《工业微生物》2025年第1期208-211,共4页Industrial Microbiology

摘　　要：文章利用ICP-MS对盐酸雷尼替丁胶囊空胶囊中二氧化钛含量的不确定度展开评估。同时,按照《化学分析中不确定度的评估指南》及《测量不确定度评定与表示》的要求和方法构建数学模型来检测空胶囊中二氧化钛含量检测的不确定度,以找出产生不确定度的原因,并计算各不确定度分量后合并。研究发现,当空胶囊中二氧化钛测定结果为9.2259 g/kg时,扩展不确定度为0.2608 g/kg,k=2;产生不确定度的最主要原因是标准溶液配制。The uncertainty of titanium dioxide content in ranitidine hydrochloride hollow capsules was evaluated by inductively coupled plasma-mass spectrometry(ICP-MS).Meanwhile,according to the requirements and methods of Guidelines for the Evaluation of Uncertainty in Chemical Analysis and Evaluation and Expression of Uncertainty in Measurement,a mathematical model was built to detect the uncertainty in the determination of titanium dioxide content in hollow capsules,aiming at finding out the reasons for the uncertainty,calculating the components of the uncertainty and combining them.The conclusion showed that when the determination result of titanium dioxide in hollow capsules was 9.2259 g/kg,the expanded uncertainty is 0.2608 g/kg,k=2.The main cause of uncertainty is the preparation of standard solution.

关 键 词：空胶囊 电感耦合等离子体质谱法 二氧化钛 不确定度 

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