HPLC测定注射用氨曲南含量的不确定度评估

Analysis of messurement uncertainty in determination of Assay for Aztreonam for injection with HPLC

目的:建立HPLC法测定注射用氨曲南含量的不确定度分析方法。方法:通过HPLC含量测定法数学模型的建立,确定不确定度来源,并对各个不确定度分量进行评定。结果:注射用氨曲南中氨曲南含量测定测合成不确定度为0.4%,扩展不确定度为0.8%。结论:测量不确定度可用于对注射用氨曲南含量测定结果的评定。

Objective：To establish a method for value of uncertainty in assay with HPLC.Method：The mathematic model was established with HPLC identified the influence factors impact uncertainty and each component of uncertainty was also evaluated..Result：The combined uncertainly was 0.4% ,the extended uncertainty was 0.8%. Conclusion：The mathematic model of uncertainty is establish for applicable to evaluate the accuracy of assay of Aztreonam for injection.