HPLC用β-内酰胺类抗生素化学对照品的不确定度分析  

Study of uncertainty of β-lactam antibiotics chemical reference substance being used in HPLC

作　　者：姚尚辰[1] 常艳[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2010年第11期2104-2110,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:考察采用所间协作标定方法与单个实验室采用质量平衡法确定β-内酰胺类抗生素化学对照品含量不确定度的差异及色谱系统适用性条件对不确定度的影响。方法:按测量不确定度原理及国家质量技术监督局发布的计量技术规范,对17个β-内酰胺类抗生素化学对照品分别采用所间协作标定的含量不确定度及单个实验室采用质量平衡法测定的含量不确定度进行比较,并研究外标法含量不确定度与色谱系统适用性条件的关系。结果:采用协作标定方式和单个实验室质量平衡法标定的含量不确定度基本一致,质量平衡法含量的不确定度略低。采用协作标定方式定值的对照品的不确定度与标定中采用的色谱系统适用性条件有关。结论:在对化学对照品进行定量时,可联合采用协作标定方式和质量平衡法两种方法进行;对于HPLC,可通过优化系统的条件降低含量的不确定度。Objective：Uncertainty in determination of β-lactam antibiotics chemical reference substance can evaluate by inter-laboratory collaborative calibration method（ILCCM）or single laboratory mass balance method（SLMBM）.The purpose was to study the difference of the uncertainty using the above two methods and the effect of the uncertainty caused by the system suitability conditions of HPLC.Methods：According to the measurement uncertainty principle and National Measurement Technology Criterion,uncertainty in determination of 17 β-lactam antibiotics chemical reference substance respectively evaluated by the above two methods were studied.And relation between uncertainty of external reference method and system suitability conditions of HPLC was observed. Results：The result showed that uncertainty of ILCCM and SLMBM are generally identical.SLMBM had a much smaller uncertainty.And the system suitability conditions have impact on uncertainty evaluated by ILCCM. Conclusion：The authors suggest that ILCCM and SLMBM can be joint use in quantification of chemical reference substance.And when using HPLC,uncertainty can be decreased by optimizing system conditions.

关 键 词：Β-内酰胺类抗生素 化学对照品 不确定度 

分 类 号：R917[医药卫生—药物分析学]