紫外-可见分光光度法测定富马酸酮替芬滴鼻液含量的不确定度分析  

Evaluation of Measurement Uncertainty in Content Determination of Ketotifen Fumarate Nasal Drops by Ultraviolet and Visible Spectrophotometry

作　　者：钱浅 何鹏 QIAN Qian;HE Peng(Wuhu Food and Drug Inspection&Testing Center,Anhui Wuhu 241000,China)

机构地区：[1]芜湖市食品药品检验检测中心,安徽芜湖241000

出　　处：《广州化工》2024年第18期79-81,共3页GuangZhou Chemical Industry

基　　金：安徽省药品监督管理局科技创新项目(编号:AHYJ-KJ-202223)。

摘　　要：建立一种紫外-可见分光光度法测定富马酸酮替芬滴鼻液含量的不确定度评定方法。按照2020年版《中国药典》二部中富马酸酮替芬滴鼻液含量测定方法,通过建立数学模型、分析、量化各实测数值不确定度分量,最终合成标准不确定度和扩展不确定度。富马酸酮替芬滴鼻液含量测定扩展不确定度U=0.22%(k=2),主要在电子天平仪器的允差和f_(对)对照品稀释过程中引入。An uncertainty evaluation method for the content determination of Ketotifen Fumarate Nasal Drops by ultraviolet-visible spectrophotometry was established.According to the 2020 edition of“Chinese Pharmacopoeia”Volume II Content determination method of Ketotifen Fumarate Nasal Drops,by establishing a mathematical model,analyzing and quantifying the uncertainty components of each measured value,the standard uncertainty and extended uncertainty were finally synthesized.The expanded uncertainty of content determination of Ketotifen Fumarate Nasal Drops was U=0.22%(k=2).The uncertainty was mainly introduced in the tolerance of the electronic balance instrument and the dilution process of the reference substance.

关 键 词：紫外-可见分光光度法 富马酸酮替芬滴鼻液 含量 不确定度 

分 类 号：R917[医药卫生—药物分析学]