高效液相色谱法测定中药注射液中的乙二胺四乙酸

目的:建立中药注射液中乙二胺四乙酸(EDTA)的高效液相色谱测定方法。方法:样品经乙酸铜溶液稀释后,用Dikma Kromasil C18柱(150 mm×4.6 mm,5μm)分离;流动相为乙腈-0.06%四丁基氢氧化铵溶液(pH6.5)(20∶80);检测波长为254 nm。结果:EDTA在46 ng～4630 ng范围内与峰面积呈良好的线性关系,r=0.9999,平均加样回收率为97.88%～102.3%。结论:该方法快速、简便,专属性强,重复性好,结果准确可靠,适用于中药注射液中EDTA的含量测定。

Determination of EDTA in Chinese medicine injection by high performance liquid chromatography

Objective:To develop a HPLC method to determine EDTA in Chinese medicine injection.Methods: The injection samples were diluted with Cu(Ac)2 solution,the sample solution was separated with Dikma Kromasil C18 chromatographic column.Acetonitrile-0.06% tetrabutyl ammonium hydroxide solution(pH 6.5)(20:80) was used as mobile phase.The detection wavelength was 254 nm.Results: The calibration curve of the method was linear within the range from 46 ng to 4630 ng(r=0.9999) with the average recoveries of 97.88%~102.3%.Conclusion: This rapid and simple method shows high specificity and reproducibility,which is suitable for the assay of EDTA in Chinese medicine injection.