非水滴定法测定西替利嗪含量的不确定度评定

目的:评估采用非水滴定法测定盐酸西替利嗪含量的测量不确定度来源,以控制药品质量。方法:建立数学模型,绘制因果图、不确定度分布图,分析温度、终点等影响含量测定不确定度的因素并合成各不确定度分量,给出扩展不确定度及包含因子。结果:各分量中滴定管的校准和终点确定引入的不确定度最大,温度影响滴定液浓度校正。结论:建立了非水滴定法测定盐酸西替利嗪含量的不确定度评价方法,确定滴定管、终点、温度是不确定度的主要来源。

Evaluating Measurement Uncertainty of Cetirizine Assay by Non-aqueous Titration

Objective： To evaluate the source of measurement uncertainty of Cetirizine hydrochloride as- say examined by non-aqueous titration to make drug quality under control. Methods： Mathematic model, cause-effect diagram and scatter gram were used to analyze various factors affecting the uncertainty such as temperature and titration-point; the component uncertainties were concluded and the expanded uncertainty and coverage factors were presented. Results： The major sources among various potential influences were the calibration of titration tub and the end point of titration, and temperature influenced the calibration of titrant concentration. Conclusion： A method of evaluating primary source of measurement uncertainty of Cetirizine hydrochloride assay by non-aqueous titration was established, and titration tub, the end point of titration and the temperature were the primary sources of measurement uncertainty.