核黄素磷酸钠中核黄素含量测定的测量不确定度评定  

Evaluation of Measurement Uncertainty on Determination of Riboflavin in Riboflavin Sodium Phosphate

作　　者：梁爱仙 陈颜清 杨雅贤 庞发根 梁智渊 殷果 王晓炜 LIANG Ai-xian;CHEN Yan-qing;YANG Ya-xian;PANG Fa-gen;LIANG Zhi-yuan;YIN Guo;WANG Xiao-wei(Shenzhen Key Laboratory of Drug Quality Standard Research,Shenzhen Institute For Drug Control,Guangdong Shenzhen 518057,China)

机构地区：[1]深圳药品质量标准研究重点实验室,深圳市药品检验研究院,广东深圳518057

出　　处：《中国药物评价》2024年第3期185-191,共7页Chinese Journal of Drug Evaluation

摘　　要：目的:建立高效液相色谱(HPLC)法分析核黄素磷酸钠中核黄素含量不确定度的评定方法,探讨影响测定核黄素含量不确定度的分量。方法:建立HPLC法测定数学模型,寻找影响不确定度的因素,对相关不确定度分量进行评定,合成标准测量不确定度,给出扩展测量不确定度报告。结果:核黄素磷酸钠中核黄素含量为2.90%,合成不确定度为0.011%,测量结果表示为(2.90±0.011)%。结论:建立了HPLC法测定核黄素磷酸钠中核黄素含量的测量不确定度评定方法,分析产生不确定度的主要来源,为有效控制核黄素含量测定方法的准确性提供可靠依据。Objective:To evaluate the measurement uncertainty on determination of riboflavin in riboflavin sodium phosphate,and the factors that affect the uncertainty by high performance liquid chromatography(HPLC).Methods:A mathematical model for the determination was established,the factors affecting the uncertainty was found,and the related uncertainty components were evaluated.The synthetic uncertainty and the expanded uncertainty of the determination by HPLC were obtained after analyzing the relative standard uncertainty of each component.Results:The content of riboflavin in riboflavin sodium phosphate was 2.90%,the synthesis uncertainty in the determination was 0.011%,the measurement result was expressed as(2.90±0.011)%.Conclusion:The method of the uncertainty evaluation for the determination of riboflavin in riboflavin sodium phosphate by HPLC method is established.The main sources of uncertainty are analyzed.This research provides a reliable theoretical basis for effectively controlling the accuracy of the determination method of sodium ion content.

关 键 词：不确定度评价 核黄素 核黄素磷酸钠 PHLC法 

分 类 号：R927.2[医药卫生—药学]