聚山梨酯80中24种金属元素的测定及分析评价  

Determination and analysis of twenty-four metallic elements in polysorbate 80

作　　者：雷雅娟 蒋贇 赵勇 李昌亮 刘雁鸣 张悦 LEI Yajuan;JIANG Yun;ZHAO Yong;LI Changliang;LIU Yanming;ZHANG Yue(Hunan Institute for Drug Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,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,长沙410001

出　　处：《中国药品标准》2024年第5期521-525,共5页Drug Standards of China

摘　　要：目的:建立电感耦合等离子体质谱法(ICP-MS)测定聚山梨酯80中24种元素含量,并进行分析评价。方法:采用ICP-MS法进行测定,通过SPSS 26软件进行统计分析,参考ICH Q3D进行元素杂质风险评估。结果:各元素在对应浓度范围内线性关系良好(r=0.997~0.999);回收率88.81%~134.64%(RSD<5%,n=6);样品中建议评估的元素均未超过推荐控制阈值。结论:该方法准确可靠、操作方便,品种整体元素杂质风险较低。Objective:To establish an inductively coupled plasma-mass spectrometry(ICP-MS)method for the determination of 24 elements in polysorbate 80,and evaluate the results.Methods:The elements were determined by ICP-MS,statistical analysis was conducted using SPSS 26,and the risk assessment was carried out with reference to ICH Q3D guidelines.Results:The standard curves showed good linear relationship in the corresponding concentration range(r=0.997-0.999).The recoveries were 88.81%-134.64%(RSD<5%,n=6).None of the elements recommended for evaluation exceeded the control threshold.Conclusion:The method is accurate,reliable and easy-to-operate,and the risk of elemental impurities in this sample is low.

关 键 词：聚山梨酯80 电感耦合等离子体质谱法 金属元素 统计分析 风险评估 

分 类 号：R921.2[医药卫生—药学]