HPLC法测定头孢克洛胶囊中头孢克洛含量不确定度评定

Uncertainty Evaluation in Determination of Cefaclor in Cefaclor Capsules by HPLC

目的分析HPLC法测定头孢克洛胶囊中头孢克洛含量的不确定度。方法通过建立数学模型,找出影响不确定度的因素、对各个不确定度分量进行评估计算、并计算合成不确定度,最终给出测量结果的扩展不确定度。结果扩展不确定度为1.6%。结论测量不确定度可用于对头孢克洛胶囊含量测定结果的评定,为测定结果的有效性及方法的优化提供科学依据。

Objective To analyze the content uncertainty of cefaclor in cefaclor capsules by HPLC. Methods By establishing an HPLC assay mathematical model,factors affecting uncertainty were deduced. Each component of uncertainty was evaluated,from which the combined uncertainty and the extended uncertainty were obtained. Results The extended uncertainty was 1. 6%. Conclusion A mathematic model of uncertainty is established,which is not only applicable for the determination of cefaclor capsules,but helps evaluate the effectiveness of assay and optimize methods.