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

Uncertainty AnaLysis of Determination of Norepinephrine Bitartrate Injection by HPLC

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 .