HPLC测定排石颗粒中芦丁含量的不确定度评定

Uncertainty analysis on HPLC method for determination of rutin in Paishi Keli

分析HPLC法测定排石颗粒中芦丁含量的不确定度。通过建立HPLC法测定含量的数学模型,找出影响不确定度的因素,并对各个不确定度因素进行评估、计算,由此计算合成不确定度,最终给出测量结果的扩展不确定度和置信水平。合成不确定度为0.026;扩展不确定度为0.007%;扩展不确定度为0.007%,排石颗粒含量/%测定结果为(0.13±0.007)%。建立HPLC法的不确定度分析与计算方法适用于颗粒制剂HPLC法含量测定不确定度评定。

The uncertainty involved in HPLC method for the determination Rutin in Paishi Keli was analysed.Through establishing the mathematical model for HPLC determination,the factors affecting the uncertainty were deduced.Each component of uncertainty was evaluated and calculated,from which the combined uncertainty and finally the extended uncertainty and confidence level were obtained.Related results were as followed：The combined uncertainty was 0.026,extended uncertainty 0.007%,and the determined content of Rutin in Paishi Keli（0.13±0.007）%.The analytical method established is applicable to the uncertainty analysis of HPLC method in the determination of drugs.