Inman E L, Clemens R L, Olsen B A
Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, IN 46285.
J Pharm Biomed Anal. 1990;8(6):513-20. doi: 10.1016/0731-7085(90)80061-s.
An LC method is described for the determination of EDTA in vancomycin formulations. EDTA is complexed with iron and the Fe(EDTA)- complex is separated from vancomycin components on a reversed-phase column using an ion pair mobile phase. Quantitation is achieved using UV detection, with absorbance ratioing employed to discriminate between the analyte and vancomycin-related compounds. The complexity of the sample matrix and the trace levels of EDTA that are of interest dictate unique development considerations. This method offers good specificity and precision over the range 20-300 ppm EDTA in vancomycin formulations, while maintaining a degree of simplicity. Wavelength selection is optimized to demonstrate the potential application of absorbance ratioing to trace determinations. This method has been effectively applied to vancomycin formulations containing a wide range of chemical impurities and is not affected by vancomycin degradation products.
描述了一种用于测定万古霉素制剂中乙二胺四乙酸（EDTA）的液相色谱法。EDTA与铁络合，Fe(EDTA)络合物在反相柱上使用离子对流动相与万古霉素组分分离。使用紫外检测进行定量，采用吸光度比值法区分分析物和万古霉素相关化合物。样品基质的复杂性以及所关注的EDTA痕量水平决定了独特的方法开发考量因素。该方法在万古霉素制剂中20 - 300 ppm的EDTA范围内具有良好的特异性和精密度，同时保持了一定程度的简便性。优化了波长选择以证明吸光度比值法在痕量测定中的潜在应用。该方法已有效地应用于含有多种化学杂质的万古霉素制剂，且不受万古霉素降解产物的影响。
