HPLC测定头孢克洛颗粒含量的不确定度评估  

Uncertainty analysis assay for Cefaclor Granules with HPLC

作　　者：邱广仁[1] 汪正宇[1] 

机构地区：[1]安徽省宿州市食品药品检验所,安徽宿州234000

出　　处：《中国现代医生》2012年第17期72-73,75,共3页China Modern Doctor

摘　　要：目的建立HPLC法测定头孢克洛颗粒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定。结果计算各分量的相对标准不确定度,由此计算合成不确定度和扩展不确定度(P=95%,K=2),从结果可看出对照品带来的不确定性较大。结论测量不确定度可用于对头孢克洛颗粒含量测定结果的评定。Objective To establish an uncertainty analysis method for Cefaclor Granules with HPLC. Methods The mathe- matic model was established with HPLC identified the influence factors impact uncertainty and each component of uncer- tainty was also evaluated. Results Each component of uncertainty was calculated by analyzed the various variable parame- ters in the procedure,the combined uncertainty and expanded uncertainty were finally obtained, the results show that the control brought greater uncertainty. Conclusion The mathematic model of uncertainty is establish for applicable to evaluate the accuracy of assay of Cefaclor Granules.

关 键 词：头孢克洛颗粒 含量 HPLC法 测量不确定度 

分 类 号：R286.0[医药卫生—中药学]