离子色谱法测定氯膦酸二钠注射液含量的测量不确定度评定  

Uncertainty Assessment for the Assay Determination of Clodronate Disodium Injection by Ion Chromatography

作　　者：杜碧莹[1] DU Biying(Guangzhou Institute for Drug Control, Guangzhou , Guangdong 510160, China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《今日药学》2017年第3期171-173,共3页Pharmacy Today

摘　　要：目的建立不确定度的数学模型,对氯膦酸二钠注射液含量的测量不确定度进行分析和评价。方法按照中国药典2015年版收载的方法,测定氯膦酸二钠注射液含量,根据《测量不确定度评定与表示》(JJF1059.1-2012),找出影响不确定度的因素,最终计算合成不确定度并得出扩展不确定度,对含量测定结果进行风险评估。结果本次实验标准合成不确定度为1.26%,扩展不确定度为2.52%,含量测定结果平均值为(99.08±2.52)%(k=2)。结论离子色谱仪的定量重复性引入的不确定度影响最大,该不确定度评定方法适用于氯膦酸二钠注射液含量的测定。OBJECTIVE To evaluate the measurement uncertainty for the assay determination of clodronate disodium injection by ion chromatography. METHODS The assay was determined by ChP 2015 method, established, and the uncertainty was appraised according to Evaluation and Expression of Uncertainty in Measurement（JJF1059.1-2012） .The various measurement uncertainties were quantified, and the evaluation results of measurement uncertainty were drawn. RESULTS The combined uncertainty was 1.26%, the expanded uncertainty was 2.52%, and the assay of clodronate disodium injection was （99.08±2.52）% （k = 2）. CONCLUSION The uncertainty originates primarily from the stability of ion chromatography. The established uncertainty evaluation method is a useful tool in assessment of assay determination of clodronate disodium injection.

关 键 词：氯膦酸二钠注射液 含量 不确定度 

分 类 号：R927.2[医药卫生—药学]