乳酸左氧氟沙星注射液光学杂质测定的不确定度评定  

Evaluation of uncertainty for the optical impurity test of Levofloxacin Lactate Injection

作　　者：刘斐 周维利 王维剑 杜亮[2] 

机构地区：[1]山东省食品药品检验研究院,山东济南250101 [2]济南军区联勤部疾病预防控制中心,山东济南250014

出　　处：《药学研究》2015年第4期212-214,共3页Journal of Pharmaceutical Research

基　　金：国家科技重大专项课题-重大新药创制(No.2009ZX09313-023)

摘　　要：目的建立盐酸左氧氟沙星注射液光学杂质测定的不确定度评定方法。方法建立数学模型,对含量测定过程中各影响因素进行分析评估。结果通过计算各变量的不确定度,合成不确定度,最终得出测定结果的扩展不确定度。结论该评定方法适用于高效液相色谱法测定乳酸左氧氟沙星光学杂质的不确定度评定。Objective To establish a method of uncertainty evaluation for the optical impurity test of Levofloxacin Lac-tate Injection. Methods The uncertainty was evaluated by an established mathematical model and the analysis of various factors affecting sample detection. Results Each componet of uncertainty was calculated and then the combined uncertainty was finally obtained by synthesizing the uncertainties of various component variables. Conclusion This method was appro-priate to be used in the uncertainty evaluation for the optical impurity test of Levofloxacin Lactate Injection.

关 键 词：左氧氟沙星 光学杂质 不确定度 

分 类 号：R927.11[医药卫生—药学]