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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 analyze the measurement uncertainty of ion chromatography determination of pamidronate disodium in injection to find out the factors affecting the uncertainty. Methods A mathematical model of ion chromatography determination of pamidronate disodium for injection was established to determine the factors affecting the uncertainty and quantified according to the relevant provisions in “Evaluation and Expression of Measurement Uncertainty” (JJF1059.1-2012) The components of uncertainty, the calculation of the synthesis of uncertainty in order to derive the measurement results of the extended uncertainty. Results The results showed that the uncertainty of determination was 0.989%, and the uncertainty of expansion was 1.98%. The content of pamidronate disodium for injection was (99.29 ± 1.98)% (k = 2) of labeled amount. Conclusion The uncertainty of the determination results mainly comes from the ion chromatography equipment, the determination of reproducibility and the impact of the reference substance. The established uncertainty assessment method is suitable for the evaluation of the uncertainty of ion chromatography determination of pamidronate disodium.