制药辅料炼蜜中5-羟甲基糠醛测定的不确定度评定  

Evaluation of Uncertainty in the Determination of 5-Hydroxymethylfurfural in Refined Honey of Pharmaceutical Excipients

作　　者：丁盈 刘英慧 方磊 Ding Ying;Liu Yinghui;Fang Lei(Hunan Food and Drug Vocational College,Changsha 410208,China;Hunan Institute of Drug Inspection and Testing,Changsha 410001,China)

机构地区：[1]湖南食品药品职业学院,湖南长沙410208 [2]湖南省药品检验检测研究院,湖南长沙410001

出　　处：《广东化工》2024年第17期182-184,共3页Guangdong Chemical Industry

基　　金：2021年度湖南省教育厅科学研究项目(21C1273);湖南食品药品职业学院校级科研创新团队建设项目资助(KCTD202201)。

摘　　要：目的:评定高效液相色谱法(HPLC)测定制药辅料炼蜜中5-羟甲基糠醛的不确定度。方法:根据《化学分析中不确定度的评估指南》CNAS-GL006-2019与《化学分析测量不确定度评定》JJF 1135-2005中的指导原则,建立相应的数学模型来分析其不确定度来源,并对各不确定度分量进行计算、评估,并整合计算出扩展不确定度。结果:不确定度主要来源为测定的重复性、标准溶液与样品溶液的配制以及高效液相色谱仪的测定。5-羟甲基糠醛含量为48.5865μg·g^(-1),扩展不确定度为1.2166μg·g^(-1)。结论:本方法可用于高效液相色谱法测定制药辅料炼蜜中5-羟甲基糠醛的不确定度评定。Objective:To evaluate the uncertainty of determination of 5-hydroxymethylfurfural in pharmaceutical excipient honey by high performance liquid chromatography(HPLC).Methods:According to the guiding principles in the“Guidelines for the Evaluation of Uncertainty in Chemical Analysis”CNAS-GL006-2019 and“Determination of Uncertainty for Chemical Analysis Measurements”JJF 1135-2005,establish a corresponding mathematical model to analyze the sources of uncertainty,calculate and evaluate each uncertainty component,and integrate to calculate the expanded uncertainty.Results:The uncertainty mainly comes from the repeatability of measurement,the preparation of standard and sample solutions,and the measurement of HPLC.The content of 5-hydroxymethylfurfural was 48.5865μg·g^(-1),with an expanded uncertainty is 1.2166μg·g^(-1).Conclusion:This method can be used to evaluate the uncertainty of the determination of 5-hydroxymethylfurfural in refined honey by liquid chromatography.

关 键 词：液相色谱法 炼蜜 五羟甲基糠醛 不确定度 

分 类 号：R917[医药卫生—药物分析学]