HPLC法测定注射用头孢他啶含量的不确定度评定  

Uncertainty assessment of the determination of ceftazidime injection by HPLC

作　　者：吴婷[1] 龙焰君[1] 张慧文[1] 李薇[1] 莫晓雪 WU Ting;LONG Yanjun;ZHANG Huiwen;LI Wei;MO Xiaoxue(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《广东药科大学学报》2023年第4期20-24,共5页Journal of Guangdong Pharmaceutical University

基　　金：广东省市场监督管理局科研项目(2021CB03)。

摘　　要：目的对HPLC法测定注射用头孢他啶的不确定度进行评定和分析,完善药品检测实验室风险控制体系。方法建立HPLC法测定注射用头孢他啶含量的数学模型,分析测量不确定度来源,并对各分量进行量化分析,评估实验室存在的风险指标。结果HPLC法测定注射用头孢他啶含量的合成相对不确定度为0.962%,扩展不确定度为1.92%,注射用头孢他啶含量测定的结果表示为(99.9±1.92)%,k=2。分析不确定度分量,引出实验室潜在的两个风险点:设备和实验操作因素。结论为有效控制注射用头孢他啶含量测定方法的准确性提供了可靠的理论依据。Objective To analyze the uncertainty assessment results of HPLC content determination and improve the risk control system of drug testing laboratories.Methods Taking ceftazidime injection as an example,a mathematical model for HPLC content determination was developed,the sources of measurement uncertainty were analyzed,and the components were quantified and analyzed to assess the risk indicators present in the laboratory.Results The synthetic relative uncertainty of 0.962%and the extended uncertainty of 1.92%for the determination of ceftazidime injection by HPLC method were expressed as(99.9±1.92)%,k=2.The analysis of the uncertainty components led to two potential risk points in the laboratory,including equipment and experimental operational factors.Conclusion This study provides a reliable theoretical basis for effective control of the accuracy of the content determination method for ceftazidime injection.

关 键 词：不确定度 注射用头孢他啶 高效液相色谱法 含量测定 风险评估 

分 类 号：R927.2[医药卫生—药学]