中国药物评价2016，Vol.33Issue(3)：129-132,4.
磷酸奥司他韦颗粒含量测定的不确定度评定
Analysis of Measurement Uncertainty in Determination of Oseltamivir Phosphate in Oseltamivir Phosphate Granules
摘要
Abstract
Objective:To establish a high performance liquid chromatography(HPLC) method for uncertainty analysis of oselta-mivir phosphate in oseltamivir phosphate granules.Methods:HPLC method was established to determinate the content of oseltami-vir phosphate in oseltamivir phosphate granules.According to its inspection process, a mathematical model was established to ana-lyze the factors affect uncertainty of oseltamivir phosphate.Each active component of uncertainty was calculated the variable parame-ters among the procedures.The combined uncertainty and extended uncertainty and confidence were finally obtained by synthesized the uncertainties of various component variables.Results:The expanded measurement uncertainty U=0.23 mg/bag(k=2).Con-clusion: Determination of content uncertainty of oseltamivir phosphate in oseltamivir phosphate granules by HPLC can lead a rather correct and dispensable result and the uncertainty is mainly gained by weighing reference, the dilution process and measuring chro-matographic peak area.关键词
磷酸奥司他韦/颗粒剂/高效液相色谱法/不确定度分析Key words
Oseltamivir phosphate/Granules/High performance liquid chromatography/Uncertainty analysis分类
医药卫生引用本文复制引用
刘肃,苏广海..磷酸奥司他韦颗粒含量测定的不确定度评定[J].中国药物评价,2016,33(3):129-132,4.
