高效液相色谱法测定甲硝唑片中甲硝唑含量的不确定度分析  

The Analysis of Measurement Uncertainty in Assay of Metronidazole Tablets with HPLC

作　　者：苗爱东[1] 王彦宗[1] 

机构地区：[1]北京军区联勤部药品仪器检验所,北京100071

出　　处：《解放军医药杂志》2012年第1期33-35,共3页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

摘　　要：目的对高效液相色谱(HPLC)法测定甲硝唑片中甲硝唑含量的测量不确定度进行分析和评价。方法通过建立HPLC法测定甲硝唑含量的数学模型,找出影响不确定度的主要因素并对各不确定度分量进行评估。结果本次甲硝唑片中甲硝唑含量测定结果为标示量的96.4%,其扩展不确定度为0.8%(k=2)。结论本试验建立的不确定度评估方法适用于HPLC法测定片剂中药物含量的不确定度评定。Objective To evaluate the measurement uncertainty in the assay of Metronidazole tablets with chromatography, high pressure liquid （ HPLC）. Methods The calculation formula of uncertainty was deduced in the procedure of determining metronidazole in tablets. Results Each component of uncertainty was calculated among the proce- dures,and combined uncertainty was finally obtained. The content of metronidazole in tablets was 96.4% in labelled amount,and the expanded uncertainty was 0.8% （k = 2）. Conclusion The mathematic model established here is suitable for uncertainty analysis in HPLC assay.

关 键 词：甲硝唑 片剂 色谱法 高压液相 不确定度 

分 类 号：R927.2[医药卫生—药学] R978