摘要
目的评定HPLC法测定双环醇片含量的不确定度。方法通过建立HPLC法测定含量的数学模型,分析测量过程,确定不确定度来源。利用统计学方法,对各量化的分量进行评定,找出影响因素。结果 HPLC法测定双环醇含量的扩展不确定度为2.0%,测量结果表示为(99.7±2.0)%,κ=2。结论 HPLC法测定双环醇含量的测量不确定度评估,方法简单合理,为双环醇片的实验室控制和客观评价提供参考。
Objective To evaluate the level of uncertainty during content determination of bicyclol tablets by HPLC.Methods A mathematic model of the HPLC quatitative method was established to identify the factors that affected the uncertainty.The influence of each factor on the results of determination was also evaluated.Results The extended uncertainty for the HPLC determination of bicyclol tablets was 2.0%,and the result of content determination was（99.7±2.0）%,κ =2.Conclusion This method of evaluation of uncertainty for the content determination of bicyclol tablets by HPLC is user-friendly and well-designed enough to guarantee the accuracy and reliability of the results.
作者
苗立红
李莉
MIAO Li-hong;LI Li(Food and Drug Safety Monitoring Center,Daxing District,Beijing 102600,China;Institute for Drug and Instrument Control of Directorate of Medical Services,Logistics Support Department,Central Military Commission of PRC,Beijing 100166,China)
出处
《解放军药学学报》
CAS
CSCD
2018年第3期245-247,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
不确定度
双环醇片
含量测定
HPLC
measurement uncertainty
bicyclol tablet
content determination
HPLC
