离子色谱法测定注射用帕米膦酸二钠含量的测量不确定度评估  

Evaluation of Measurement Uncertainty for the Determination of Pamidronate Disodium for Injection by Ion Chromatography

作　　者：曹琳 钱江[2] 

机构地区：[1]宁波市药品检验所,浙江宁波315048 [2]浙江医药高等专科学校,浙江宁波315100

出　　处：《中国现代应用药学》2016年第4期448-451,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的对离子色谱法测定注射用帕米膦酸二钠含量的测量不确定度进行分析,以找出影响不确定度的因素。方法建立离子色谱法测定注射用帕米膦酸二钠含量的数学模型,确定影响不确定度的因素,并根据《测量不确定度评定与表示》(JJF1059.1-2012)中有关规定,量化各不确定度分量,计算合成不确定度从而得出测定结果的扩展不确定度。结果测定结果的合成不确定度为0.989%,扩展不确定度为1.98%,注射用帕米膦酸二钠的含量为标示量的(99.29±1.98)%(k=2)。结论测定结果的不确定度主要来源于离子色谱仪器、测定的重复性以及对照品的影响。建立的不确定度评估方法适用于离子色谱法测定注射用帕米膦酸二钠含量的不确定度评估。OBJECTIVE To evaluate the measurement uncertainty for the determination of pamidronate disodium for injection by ion chromatography, and find out the effect factors. METHODS The mathematical model was established, and the uncertainty was appraised according to JJF1059.1-2012. The various measurement uncertainties were quantified, and the evaluation results of measurement uncertainty were drawn. RESULTS The combined uncertainty was 0.989%, the expanded uncertainty was 1.98%, and the content ofpamidronate disodium was （99.294-1.98）% （k=-2）. CONCLUSION The uncertainty originates primarily from the stability of ion chromatography, the repeatability and the reference substance. This uncertainty evaluation method can be used for uncertainty analysis in the determination of pamidronate disodium for injection by ion chromatography.

关 键 词：离子色谱法 注射用帕米膦酸二钠 不确定度评估 

分 类 号：R917[医药卫生—药物分析学]