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

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.