电位滴定法测定格列齐特片含量的不确定度评定

Valuation of Uncertainty for Determination of Gliclazide Tables by Potentiometric Titration

目的:评定电位滴定法测定格列齐特片含量的不确定度。方法:对电位滴定法测定格列齐特片含量的全过程进行分析,建立不确定度的数学模型,找出评估不确定度的影响因素,并对各个不确定度分量进行评估,计算合成标准不确定度和扩展不确定度。结果:电位滴定法测定格列齐特片含量的合成标准不确定度为0.334%,扩展不确定度为0.7%(k=2)。结论:该法适用于电位滴定法测定格列齐特片含量的不确定度评定。

Objective:To evaluate the level of uncertainty during content determination of Gliclazide tables by potentiometric titration.Methods:According to the whole process of Gliclazide tables by potentiometric titration,a mathematical model was established to identify the factors that affected the uncertainty.Each active component of uncertainty was calculated the variable parameters among the procedures.The combined uncertainty and the extended uncertainty were finally obtained by synthesized the uncertainties of various component variables.Results:The combined uncertainty for the determination of the Gliclazide tables by potentiometric titration was 0.506%,and the extended uncertainty was 0.7%(k=2).Conclusion:The method was suitable for the evaluation of measurement uncertainty for content determination of Gliclazide tables by potentiometric titration.