摘要
目的:采用高效液相色谱(HPLC)法测定盐酸利多卡因注射液中盐酸利多卡因的含量,对其不确定度进行评定。方法:根据CNAS-GL006-2019《化学分析中不确定度的评估指南》、JJF1059.1-2012《测量不确定度评定与表示》要求,建立不确定度评估的数学模型,对其各主要分量进行分析,得出合成不确定度以及扩展不确定度,最终进行含量测定结果不确定度评定。结果:HPLC法测定盐酸利多卡因含量合成不确定度为0.243%,扩展不确定度为0.49%,盐酸利多卡因含量测定结果表示为(101.3±0.49)%,k=2。结论:移液管移取样品的准确性是试验中不确定度的主要来源。
Objective:To evaluate the uncertainty in content determination of Lidocaine Hydrochloride Injection by HPLC.Methods:According to CNAS-GL006-2019 and JJF1059.1-2012,establish a mathematical model of uncertainty evaluation,analyze and calculate the main components of uncertainty,and obtain the combined uncertainty and the expanded uncertainty,which are finally measured uncertainty evaluation of results.Results:The conbined uncertainty in the determination is 0.243%,and the expanded uncertainty is 0.49%.The content of lidocaine hydrochloride is(101.3±0.49)%,k=2.Conclusion:The uncertainty of the method is mainly caused by the accuracy of pipetting samples.
作者
张志超
袁晓转
韩慧丽
ZHANG Zhi-chao;YUAN Xiao-zhuan;HAN Hui-li(Luoyang Institute for Food and Drug Control,Henan Luoyang 471000,China;The First Affiliated Hospital of Henan University of Science and Technology,Henan Luoyang 471000,China)
出处
《中国药物评价》
2021年第3期202-205,共4页
Chinese Journal of Drug Evaluation
关键词
盐酸利多卡因注射液
高效液相色谱
含量测定
测量不确定度评定
Lidocaine hydrochloride injection
High Performance Liquid Chromatography(HPLC)
Content determination
Uncertainty evaluation
