论文部分内容阅读
目的:建立HPLC法标定左氧氟沙星杂质A对照品含量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HPLC法标定左氧氟沙星杂质A对照品含量的不确定度评定。
Objective: To establish an HPLC method for the determination of levofloxacin impurity A reference substance content uncertainty assessment method. Methods: To establish a mathematical model to analyze and evaluate the influential factors in the determination of content. Results: By calculating the uncertainty of each variable, the uncertainty was synthesized and finally the extended uncertainty of the measurement results was obtained. Conclusion: This method is suitable for the evaluation of the uncertainty of HPLC method for the determination of levofloxacin impurity A reference substance.