HPLC法测定罗红霉素胶囊含量的不确定度分析

摘要

Objective:To establish a method of uncertainly evaluation for Roxithromycin Capsules with HPLC. Methods The mathe-matic model was established with HPLC to identify the factors influencing uncertainly and each compinent of uncertainly was also evaluated. Result The combined uncertainly was 0.6%,the extended uncertainly was 1.2%. Conclusion The mathematic model of uncertainly established is applicable to evaluate the accuracy of assay of Roxithromycin Capsules.%目的：建立HPLC法测定罗红霉素胶囊含量的不确定度分析方法。方法：通过建立HPLC含量测定法的数学模型，确定影响不确定度的因素，并对各不确定度因素进行评估。结果：罗红霉素胶囊中罗红霉素含量测定的合成不确定度为0.6%，扩展不确定度分别为1.2%（K=2）。结论：本方法可用于对罗红霉素胶囊含量测定结果的评定。