高效液相色谱法测定盐酸多巴酚丁胺注射液中盐酸多巴酚丁胺的不确定度评定  

Evaluation of uncertainty for determination of dobutamine hydrochloride in dobutamine hydrochloride injection by high performance liquid chromatography

作　　者：许倩 汪海宣 刘静 陈扣宝 汪梦美 XU Qian;WANG Haixuan;LIU Jing;CHEN Koubao;WANG Mengmei(Hefei Food and Drug Control Center,HeFei 230001,China)

机构地区：[1]合肥市食品药品检验中心,合肥230001

出　　处：《化学分析计量》2022年第9期75-78,共4页Chemical Analysis And Meterage

摘　　要：评定高效液相色谱法测定盐酸多巴酚丁胺注射液中盐酸多巴酚丁胺含量的不确定度。建立测量值与输入量的数学模型,分别分析各不确定度分量,最终合成相对标准不确定度和扩展不确定度。当盐酸多巴酚丁胺含量为99.0%时,扩展不确定度为0.80%(k=2)。高效液相色谱法测定盐酸多巴酚丁胺注射液中盐酸多巴酚丁胺含量的不确定度的来源主要是天平称量误差、人员制备样品过程、仪器测量重复性,其中天平称量和样品溶液定容对测定结果影响较大。The uncertainty of determination of dobutamine hydrochloride in dobutamine hydrochloride injection by high performance liquid chromatography was evaluated.The mathematical model of measured value and input was established,and each component was analyzed respectively to synthesize the relative standard uncertainty and extended uncertainty.When the dobutamine hydrochloride content was 99.0%,the extended uncertainty was 0.80% (k=2).The uncertainty of determination of dobutamine hydrochloride in dobutamine hydrochloride injection by high performance liquid chromatography was mainly derived from balance weighing error,sample preparation process and instrument measurement repeatability.The results showed that the balance weighing and constant volume had great influence onthe results.

关 键 词：高效液相色谱法 测量不确定度 盐酸多巴酚丁胺 

分 类 号：O657.3[理学—分析化学]