HPLC法测定硝酸咪康唑栓含量的不确定度分析

Uncertainty analysis assay for miconazole nitrate suppositories with HPLC

目的:建立 HPLC 法测定硝酸咪康唑栓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,找出影响不确定度的因素并对各个不确定度分量进行评估。结果:计算各变量的不确定度,由此计算合成不确定度,最终给出了测定结果的扩展不确定度和置信水平。结论:测量不确定度可用于对硝酸咪康唑含量测定结果的评估;建立的方法适用于HPLC 法测定各类制剂含量的不确定度分析。

Objective： To establish a method for value of uncertainty in assay with HPLC. Methods： The calculation formula for the uncertainty was deduced in the procedure of assay for the suppositories. Results： The uncertainty for each factor was calculated by analyzing the variable parameters among the procedure. The combined uncertainty was finally obtained by synthesizing the uncertainties for the factors. Conclusion： The mathematic model of uncertainty of measurement established in this paper is reasonable and reliable. It is applicable to evaluate the accuracy of assay for suppositories with HPLC.