摘要
采用分光光度法测定盐酸吗啡片含量,对测定结果的不确定度进行评定。依据《中国药典》2020年版二部通则0401和JJF 1059.1—2012《测量不确定度评定与表示》,建立数学模型,分析不确定度来源。测量不确定度的主要来源包括:标准物质纯度、测量重复性、天平称量、溶液配制,其中标准物质纯度、溶液配制和天平称量对不确定度的影响较大。当置信区间为95%时,盐酸吗啡片含量测定结果为(5.003±0.0287)mg(k=2)。盐酸吗啡片含量测量不确定度的准确评定,有助于控制药品的检测质量。
The content of morphine hydrochloride tablets was determined by spectrophotometry,and the uncertainty of the determination results was evaluated.According to“Chinese Pharmacopoeia”2020 edition two general rules 0401 and JJF 1059.1–2012“Measurement Uncertainty Evaluation and Representation”,the mathematical models were established to analyze the source of uncertainty.The main sources of measurement uncertainty include:purity of reference materials,measurement repeatability,balance weighing and solution preparation.The purity of reference materials,solution preparation and balance weighing had a great impact on the uncertainty.When the confidence interval was 95%,the content determination result of morphine hydrochloride tablets was(5.003±0.0287)mg(k=2).The accurate assessment of the uncertainty of the content of morphine hydrochloride tablets is helpful to control the testing quality of drugs.
作者
蒋咏梅
汪海宣
程庆兵
陶俊钰
JIANG Yongmei;WANG Haixuan;CHENG Qingbing;TAO Junyu(Hefei Food and Drug Control Center,HeFei 230006,China)
出处
《化学分析计量》
CAS
2022年第7期86-89,共4页
Chemical Analysis And Meterage
关键词
分光光度法
盐酸吗啡
不确定度
质量控制
spectrophotometry
morphine hydrochloride
uncertainty
quality control
