HPLC同时测定护肝片中5种成分的不确定度分析

Uncertainty Analysis for five effective components in Hugan Tabelts by HPLC

目的:建立HPLC法测定护肝片中腺苷、五味子醇甲、五味子酯甲、五味子甲素和五味子乙素的不确定度评定方法。方法:根据《测量不确定度评定与表示》的有关规定,分析影响含量结果不确定度的因素来源,并对各不确定度因素进行评定,计算合成不确定度,最终给出扩展不确定度和报告不确定度。结果:不确定度评估为腺苷±0.81%,五味子醇甲±0.86%,五味子酯甲±0.67%,五味子甲素±0.74%,五味子乙素±0.78%。结论:对照品的配制、样品溶液、进样重复性的不确定度是肝片5种成分不确定度的主要来源。

Objective To establish a HPLC method for uncertainty analysis of Adenosine, Schisandrin, Schisantherin, Deoxy- schizandrin and Schisandrin B in Hugan Tabelts. Methods According to the technical requirements of Evaluation and expression of uncertainty in measurement, each active component of uncertainty was calculated the variable parameters among the procedures. The combined uncertainty and extended uncertainty reported Uncertainty were finally obtained by synthesized the uncertainties of various component variables. Results The uncertainty for Adenosine was ＋ O. 81%, Schisandrin Was ~ 0. 86% , Schisantherin was ＋ 0.67%, Deoxyschizandrin was ＋0. 74% and Schisandrin B was ＋ 0. 78%. Conclusion The uncertainty of reference standard qualrity was the main source of five components measurement uncertainty in Hugan Tabelts.