应用离子对HPLC-ELSD法测定磷霉素钠中磷霉素及有关物质的含量

摘要

An ion-pair HPLC with evaporative light-scattering detection(ELSD)method for the determination of fosfomycin and related substances in fosfomycin sodium was developed.Utilizing an ODS column at 35℃,evaporation temperature of 45℃ and nebulizing gas pressure of 0.35MPa,the optimized mobile phase was 0.015mol/L octylamine solution (adjusted to pH5.2 with glacial acetic acid): acetonitrile(90:10).The linear range for fosfomycin and disodium 1,2-(dihydroxypropyl) phosphonate (diol substance) was 26.0～207.7μg/ml and 7.6～60.6μg/ml respectively.Limit of quantitation was 8.7/μg/ml for fosfomycin and 7.7 μg/ml for disodium 1,2-(dihydroxypropyl)phosphonate respectively.%建立了HPLC-ELSD法测定磷霉素钠中磷霉素及有关物质的含量.采用ODS柱,柱温35℃,以0.015mol/L正辛胺溶液(用冰乙酸调节pH至5.2):乙腈(90:10)为流动相,蒸发光散射检测器温度为45℃,雾化气体压力为0.35MPa.磷霉素及其二醇物分别在26.0～207.7和7.6～60.6μg/ml范围内呈良好的线性关系,两者的定量限分别为8.7和7.7μg/ml.