离子色谱法测定阿仑膦酸钠片含量的不确定度评定

Evaluation of uncertainty for determination of alendronate sodium tablets by ion chromatography

对离子色谱法测定阿伦膦酸钠片含量进行不确定度评定。依据《中国药典》和JJF 1059.1-012《测量不确定度评定与表示》,确定阿伦膦酸钠片含量测定过程的不确定度来源包括测量重复性、天平称量、定容体积、测量仪器。建立测量值与输入量的数学模型,分别评价各不确定度分量,最终合成标准不确定度及扩展不确定度。阿伦膦酸钠片含量为98.5%,相对扩展不确定度为1.48%(k=2)。离子色谱法测定阿伦膦酸钠片的不确定度主要来自样品的定容体积和样品称量。

The uncertainty of determination of alendronate sodium tablets by ion chromatography was evaluated.According to Chinese Pharmacopoeia and JJF 1059.1-012 evaluation and expression of measurement uncertainty,the sources of uncertainty in the determination of alendronate sodium tablets were determined,including measurement repeatability,balance weighing,constant volume,and measuring instruments.The mathematical models of measured value and input value were established to evaluate each uncertainty component respectively,and finally the standard uncertainty and expanded uncertainty were synthesized.The content of alendronate sodium tablets was 98.5%,and the relative expanded uncertainty was 1.48%(k=2).The uncertainty of determination of alendronate sodium tablets by ion chromatography mainly come from the constant volume of the sample and the sample weighing.