电位滴定法测定能力验证样品含量的不确定度评定  

Evaluation of Uncertainty for the Determination of Proficiency Testing Samples by the Potentiometric Titration

作　　者：杨梅 伍良涌[1] 李玮玲[1] 邱娟[1] YANG Mei;WU Liangyong;LI Weiling;QIU Juan(Guangzhou Institute for Drug Control,Guangzhou,Guangdong,China 510160)

机构地区：[1]广东省广州市药品检验所,广东广州510160

出　　处：《中国药业》2024年第17期104-107,共4页China Pharmaceuticals

基　　金：欧洲药品质量管理局(EDQM)能力验证项目[PTS236]。

摘　　要：目的评定电位滴定法测定能力验证样品含量的不确定度,探讨影响测定的不确定度分量。方法采用电位滴定法测定门冬酰胺一水合物及门冬氨酸含量。建立测量模型,分析不确定度来源,计算各分量的相对标准不确定度及2种样品的合成不确定度。结果门冬酰胺一水合物含量为87.53%,合成标准不确定度为0.24%;门冬氨酸含量为99.68%,合成标准不确定度为0.22%。结论建立了电位滴定法测定能力验证样品含量的不确定度评定方法,且验证结果满意,可为能力验证样品含量测定结果的可信度提供支持。Objective To evaluate the uncertainty for the determination of proficiency testing samples by potentiometric titration,and to investigate the uncertainty components affecting the evaluation.Methods Potentiometric titration was used to determine the content of asparagine monohydrate and aspartic acid.The evaluation model was established to analyze the sources of uncertainty,and calculate the relative standard uncertainty of sub-scales and the composite uncertainty of two samples.Results The content of asparagine monohydrate was 87.53%,and the combined standard uncertainty was 0.24%.The content of aspartic acid was 99.68%,and the combined standard uncertainty was 0.22%.Conclusion The method of the uncertainty evaluation for the determination of proficiency testing samples is established,and the results of the proficiency testing are satisfied,which can provide a support for the credibility of the results of the content determination of proficiency testing samples.

关 键 词：电位滴定法 不确定度 能力验证 门冬酰胺一水合物 门冬氨酸 含量测定 

分 类 号：R927.2[医药卫生—药学] R975.5