HPLC法测定拉米夫定片剂含量的不确定度评定  

Uncertainty Evaluation for Content Determination of Lamivudine Tablets by HPLC

作　　者：林珍[1] 姚文松 吴娜梅 林新华[1] 

机构地区：[1]福建医科大学药学院药物分析系,福州350004 [2]福建广生堂药业股份有限公司,福州350003

出　　处：《中国药房》2015年第21期2968-2970,共3页China Pharmacy

基　　金：国家自然科学基金资助项目(No.21305015);福建省自然科学基金资助项目(No.2014J05014);2012年福建医科大学博士科研启动基金

摘　　要：目的:建立HPLC法测定拉米夫定片含量的不确定度评定方法。方法:建立HPLC法测定拉米夫定片剂含量的数学模型,分析不确定度来源,并对各个不确定度分量、合成不确定度进行评估,得出扩展不确定度。结果:HPLC法测定拉米夫定片含量的不确定度主要来自于对照品的纯度、对照品的称量、玻璃器皿的允差。含量测定的标准不确定度为0.21%,扩展不确定度为0.42%。含量测定结果表示为(99.76±0.42)%,包含因子k=2。结论:该方法适用于HPLC法测定拉米夫定片剂含量的不确定度评定,可为拉米夫定片的实验室质量控制和客观评价提供参考。OBJECTIVE：To establish a method for the uncertainty evaluation of determining content of Lamivudine tablets by HPLC. METHODS：HPLC was established to determine the mathematical model of Lamivudine tablets contents,analyze the uncertainty sources in detail and evaluate each uncertainty components and combined uncertainty to obtain the expanded uncertainty. RESULTS：Uncertainty of Lamivudine tablets contents determined by HPLC was mainly from reference purity,weighing standard and glassware tolerance. Standard uncertainty was 0.21% and expanded uncertainty was 0.42%. The range of content determination was（99.76±0.42）%,k=2. CONCLUSIONS：The method is suitable for uncertainty evaluation of Lamivudine tablets by HPLC,and provides reference for the quality control in laboratory and objective evaluation of Lamivudine tablets.

关 键 词：不确定度 拉米夫定 片剂 含量测定 

分 类 号：R917[医药卫生—药物分析学]