用HPLC法测定黄麦合剂中淫羊藿苷含量的不确定度分析  

Uncertainty analysis of content determination of icariin in Huangmai mixture by HPLC method

作　　者：孙黎[1] 苏克剑[1] 金冠钦[1] 

机构地区：[1]上海交通大学医学院附属仁济医院药剂科,上海200001

出　　处：《药学服务与研究》2012年第6期434-437,共4页Pharmaceutical Care and Research

基　　金：上海市浦东新区科技局中医药创新体系项目(No.PKM2010-13)

摘　　要：目的:建立HPLC法测定黄麦合剂中淫羊藿苷含量的不确定度分析方法。方法:对HPLC法测定淫羊藿苷含量的流程进行分析,确定不确定度来源,得出扩展不确定度。结果:HPLC法测定黄麦合剂中淫羊藿苷含量的不确定度的主要因素包括对照品溶液配制、样品制备、重复性、拟合回归模型和其他因素,扩展不确定度为0.039μg/ml,含量测定结果为(5.299±0.039)μg/ml,k=2。结论:该方法可作为HPLC法测定淫羊藿苷含量不确定度评定的参考。Objective： To establish a method of evaluating the uncertainty of content determination of icariin in Huangmai mixture by HPLC method.Methods： Uncertainty sources were obtained by analyzing the procedures of HPLC method and expanded uncertainty were thus calculated.Results： Main sources of uncertainty of content determination of icariin in Huangmai mixture included preparation of control solution,preparation of samples,reproducibility,fitting regression model and other factors.The expanded uncertainty was 0.039 μg/ml,and the result of content determination was expanded as（5.299±0.039） μg/ml,k=2.Conclusion： The method could provide evidence for uncertainty analysis of content determination of icariin in Huangmai mixture by HPLC method.

关 键 词：不确定度分析 淫羊藿苷 黄麦合剂 色谱法 高效液相 

分 类 号：R927.2[医药卫生—药学]