HPLC法测定肝素钠原料中EDTA-2Na的残留

Determination of residues of EDTA-2Na in raw heparin sodium by HPLC

目的：建立肝素钠原料中EDTA-2Na的残留测定方法。方法：色谱柱：Wonda Sil-C18（200mm×4.6mm×5μm）;流动相：p H为3.0的0.025mol/l硫酸铵溶液;检测波长：254nm;检测温度：室温;流速：1.0ml/min;进样量：20μl。结果：EDTA-2Na在0.1-1.5μg/ml浓度范围内具有良好的线性关系,平均回收率为100.09%,RSD为1.0%。结论：本法测定肝素钠中EDTA-2Na具有良好的专属性、线性、重复性和准确度,适用于EDTA-2Na的检测。

Objective To establish the method for determination of the residues of EDTA - 2Na in raw heparin sodium. Method The chromatographic column is WondaSil - C18 （200mm×4.6mm×5μm） ; mobile phase 0. 025mol,/1 ammonium sulfate （pH 3.0 ） ; the column temperature is room temperature ; detection wavelength is 254nm ; the flow rate is 1.0ml · min ^- 1 ; the amount of injection is 20ul. Results The chromatographic method to detect the use of heparin raw material in EDTA -2Na is accurate, and the calibration curve of disodium edetate is linear in the range of 0. 1 - 1.5μg/ml. the average recovery was 100.09% , RSD was 1.0%. Conclusion The method is accurate, reproducible which can be used for the residues of EDTA -2Na in raw heparin sodium.