HPLC法测定地塞米松磷酸钠注射液含量的不确定度分析

Uncertainty analysis assay for dexamethasone sodium phosphate injection with HPLC

目的:建立HPLC法测定地塞米松磷酸钠注射液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,最终给出测定结果的扩展不确定度。结论:测量不确定度可用于对地塞米松磷酸钠含量测定结果的评价,测量不确定度的评定对于药品检验具有重要意义。

Objective： To establish an uncertainty analysis method for assay of dexamethasone sodium phosphate injection with HPLC. Methods： A mathematic model was established with HPLC to identify the influence factors impacting uncertainty and each component of uncertainty was also evaluated. Resuits： Each component of uncertainty was calculated by analyzing the various variable parameters in the procedure, the combined uncertainty and expanded uncertainty were finally obtained. Conclusion： The mathematic model of uncertainty was established in this paper is applicable to evaluate the accuracy of assay of dexamethasone sodium phosphate injection. The establishment of the methodology for the evaluation of measurement uncertainty is important in drug control.