非水滴定法测定药物含量的不确定度评定
滴定法,,药品；滴定法；含量测定；不确定度,1实验部分,2结果与讨论,3总结,参考文献
摘 要 目的 通过高氯酸液滴定药物含量不确定度的评价,建立普遍适用于滴定法测定药物含量的不确定度评定方法。方法 分析标准溶液制备中引入的标准溶液浓度的不确定度,供试品测定时的各种影响因素并对各个不确定度分量进行评估。结果 计算各变量的不确定度，由此计算合成不确定度，最终给出测量结果的扩展不确定度。结论 建立的不确定度计算方法适用于滴定法定量测定药物含量不确定度的评价。关键词 药品；滴定法；含量测定；不确定度
Evaluation of the uncertainty of nonaqueous titration in pharmaceutical analysis
WU Qiongshi,LI Guangyao,WANG Yu
(1.Hainan Provincial People’s Hospital, Haikou 570311, China; 2.Hainan Sanye Pharmaceutical Factory Co. Ltd, Haikou 570226, China; 3. Jiangsu Institute for Drug Control, Nanjing 210008, China)
Abstract Objective To establish a method for uncertainty evaluation in nonaqueous titration with perchloric acid. Methods and Results The calculation formula of uncertainty was deduced from the procedure of titration. The concentration uncertainty from the preparation of standard solutions and the factors affecting sample detection were analyzed. Each component of uncertainty was calculated by analyzing the various variable parameters in the procedure.The combined uncertainties were then finally obtained by synthesizing the uncertainties of various component variables. Conclusion This mathematic model of uncertainty estimation is reasonable and reliable. ......
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