乳酸左氧氟沙星中乳酸含量的测定分析

Determination of lactic acid content in Levofloxacin lactate

目的:对乳酸左氧氟沙星中的乳酸含量进行测定,以找到一种高效、快速测定左氧氟沙星中乳酸含量的方法,为质量标准的制定提供参考。方法:以高效液相色谱(HPLC)法,并基于乳酸左氧氟沙星的特性进行优化,测定其中的乳酸含量。结果:HPLC法在乳酸左氧氟沙星乳酸含量的测定中,从USP理论塔板数、拖尾因子、主峰峰面积方面分析与标准要求均符合。曲线回归方程表明该方法具有较好的线性关系,获得检测限、定量限、峰面积数据表明该方法具有较好的精密度,主峰的峰面积表明该方法具有较好的重复性,中间精密度试验表明该方法具有较好的重现性,平均回收率表明该方法具有较好的准确度,且24 h内供试品溶液的稳定性良好。结论:针对乳酸左氧氟沙星中乳酸含量的测定,采用HPLC法可获得准确信息,为质量控制提供指导。

Objective:To determine the content of lactic acid in Levofloxacin lactate,in order to find an efficient and rapid method to determine the content of lactic acid in Levofloxacin lactate,and to provide reference for the formulation of quality standards.Methods:The content of lactic acid in Levofloxacin lactate was determined by high performance liquid chromatography(HPLC).Results:In the determination of levofloxacin lactate content by HPLC,the analysis of theoretical plate number,trailing factor and main peak-peak area of levofloxacin lactate met the standard requirements.The curve regression equation shows that the method has a good linear relationship,the obtained detection limit,quantitation limit and peak area data show that the method has a good precision,the peak area of the main peak shows that the method has a good repeatability,the intermediate precision test shows that the method has a good reproducibility,and the average recovery rate shows that the method has a good accuracy.The stability of the tested solution was good within 24 h.Conclusions:For the determination of lactic acid content in Levofloxacin lactate,HPLC method can obtain accurate information and provide guidance for quality control.