高效液相色谱法测定盐酸依托必利片含量的不确定度分析  

Analysis of Uncertainty in Determination of Etopril Hydrochloride Tablets by High Performance Liquid Chromatography

作　　者：荀秀彪 张顺平 XUN Xiu-biao;ZHANG Shun-ping(Qujing Food and Drug Inspection and Testing Center,Qujing 655000,Yunnan,China)

机构地区：[1]云南省曲靖市食品药品检验检测中心

出　　处：《医学信息》2020年第4期181-183,共3页Journal of Medical Information

摘　　要：目的建立高效液相色谱法(HPLC)测定盐酸伊托必利片含量测量的不确定度评定方法。方法通过建立高效液相色谱法测定盐酸伊托必利片含量的数学模型,分析不确定度的来源,并对各个不确定度分量、合成不确定度进行评估,得出扩展不确定度。结果高效液相色谱法测定盐酸伊托必利片含量为99.70%,置信概率P为95.00%时,其扩展不确定度为3.59%,测定结果可以表示为(99.70±3.59)%,k=2。结论该法可用于高效液相色谱法测定盐酸伊托必利片含量的不确定度分析。Objective To establish a method for the evaluation of uncertainty in the determination of the content of ittopril hydrochloride by high performance liquid chromatography(HPLC).Methods By establishing a high performance liquid chromatography mathematical model for determining the content of ittopril hydrochloride,the sources of uncertainty were analyzed,and evaluate each uncertainty component and synthetic uncertainty,the extended uncertainty is obtained.Results The high-performance liquid chromatography method for determining the content of itolibril hydrochloride tablets was 99.70%.When the confidence probability P was 95.00%,the expanded uncertainty was 3.59%,the measurement result can be expressed as(99.70±3.59)%,k=2.Conclusion This method can be used for uncertainty analysis of high-performance liquid chromatography determination of ittopril hydrochloride.

关 键 词：高效液相色谱法 盐酸伊托必利片 含量测定 不确定度 

分 类 号：R286[医药卫生—中药学]