HPLC法测定阿奇霉素颗粒含量的不确定度研究

Uncertainty of Content Determination of Azithromycin Granules by HPLC

目的:采用高效液相色谱(HPLC)法分析阿奇霉素颗粒含量不确定度的来源,及影响其不确定度的因素。方法:建立HPLC法测定数学模型寻找影响不确定度的因素并对相关不确定度分量进行评定。对各分量的相对标准不确定度进行分析得出含量合成不确定度以及扩展不确定度。结果:高效液相色谱法测定阿奇霉素颗粒含量,在95%置信水平下,k=2时,合成不确定度为0.53%,其扩展不确定度为1.06%,测量结果表示为(99.5±1.06)%。结论:阿奇霉素颗粒含量测定不确定度实验显示,定容体积及测量方法的重复性是相对不确定度的主要来源。

Objective:To analyze the source of uncertainty in content determination of azithromycin granules and the factors that affect the uncertainty by high performance liquid chromatography(HPLC).Methods:A mathematical model for the determination was established,the factors affecting the uncertainty was found,and the related uncertainty components were evaluated.The synthetic uncertainty and the expanded uncertainty of the determination by HPLC were obtained after analyzing the relative standard uncertainty of each component.Results:The synthesis uncertainty in the determination was 0.53%,and the expanded uncertainty was 1.06%,the measurement result was expressed as(99.5±1.06)%at the 95%confidence level as k=2.Conclusion:Azithromycin granule uncertainty of the method were mainly caused by the constant volume and the repeatability.