摘要
目的对高效液相色谱法(HPLC)测定替硝唑片中替硝唑含量的不确定度进行分析和评价。方法通过建立替硝唑含量测定的数学模型,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。结果本次替硝唑片中替硝唑含量测定结果为标示量的94.1%,其扩展不确定度为1.3%(k=2)。结论本试验所建立的不确定度评估方法适用于HPLC法测定替硝唑片含量的不确定度评定。
Objective To evaluate and analyze high performance liquid chromatography （HPLC） in uncertainty detection of Tinidazole content in Tinidazole tablets. Methods The uncertainty causes of influencing factors were found out, and uncertainty components were also evaluated by establishing detected uncertainty calculation formula. Results The content of Tinidazole in tablets was 94.1% in labelled amount, and the expanded uncertainty was 1.3% （ k = 2）. Conclusion The established Tinidazole model is suitable for uncertainty analysis by HPLC.
出处
《解放军医药杂志》
CAS
2012年第12期28-31,共4页
Medical & Pharmaceutical Journal of Chinese People’s Liberation Army
关键词
替硝唑
片剂
色谱法
高压液相
不确定度
Tinidazole
Tablet
Chromatography, high pressure liquid
Uncertainty
