HPLC法测定重酒石酸去甲肾上腺素注射液含量的不确定度分析

摘要

目的：建立HPLC法测定重酒石酸去甲肾上腺素注射液含量不确定度的分析方法。方法：建立数学模型，分析影响不确定度的因素，对各个不确定度进行评估。结果：扩展不确定度为U=0.62％（k=2），含量测定结果为（94.8±1.3）％。结论：建立的不确定度方法可适用于HPLC法测定重酒石酸去甲肾上腺素注射液含量的不确定度分析。%Objective:To estabLish a method of uncertainty anaLysis for Norepinephrine Bitartrate Injection with HPLC .Methods: Through estabLishing mathematicaL mode,the factors infLuencing the uncertainty was anaLyzed ,each component of the uncertainty was assessed. ResuLts:the extended uncertainLy was 0.62%(k=2),and the determined content were 94.8%±1.3%.ConcLusion:This mathematic modeL of uncertainty estimation is reasonabLe for t Norepinephrine Bitartrate Injection with HPLC .