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(英文)

Application of ion-pair HPLC-ELSD for the determination of fosfomycin and related substances in fosfomycin sodium

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0.015m o l/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0.35M Pa。磷霉素及其二醇物分别在26.0～207.7和7.6～60.6μg/m l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/m l。

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 35C, evaporation temperature of 45℃ and nebulizing was 0. 015mol/L octylamine solution （adjusted to pH5. gas pressure of 0.35MPa, the optimized mobile phase 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. 7μg/ml for fosfomycin and 7.7 μg/ml for disodium 1,2- （dihydroxypropyl） phosphonate respectively.