摘要
目的对马来酸氯苯那敏片HPLC含量测定方法的不确定度进行评估。方法建立HPLC法测定马来酸氯苯那敏片含量的数学模型,确定影响不确定度的因素,并根据新版《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,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0.75%,扩展不确定度为1.5%,马来酸氯苯那敏片含量为97.7%±1.5%(k=2)。结论测定结果的不确定度主要来源于测定的重复性不确定度分量、高效液相仪器以及对照品的影响。建立的不确定度评估方法适用于HPLC法测定制剂含量的不确定度。
Objective To establish a method for the uncertainty analysis of Chlorpheniramine Maleate Tablets by HPLC method . Methods The mathematical model for determining the content in Chlorpheniramine Maleate Tablets by HPLC method was estab‐lished ,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 .75% ,the expanded uncertainty was 1 .5% ,and the content of chlorpheniramine maleate was 97 .7% ± 1 .5% （k=2） .Conclusion The uncertainty o‐riginated primarily from the repeatability ,the stability of HPLC and the reference substance .The established mathematical model of uncertainty measurement is reasonable and reliable for the uncertainty detection of various preparations .
出处
《西北药学杂志》
CAS
2015年第5期581-584,共4页
Northwest Pharmaceutical Journal
