高效液相色谱-蒸发光散射检测法测定磷霉素钙胶囊含量

Content determination of fosfomycin calcium capsules by HPLC-ELSD

目的建立高效液相色谱-蒸发光散射检测法测定磷霉素钙胶囊含量。方法用PrevailC18(4.6mm×250mm,5μm)色谱柱,以0.25mol/L三氟乙酸水溶液为流动相,流速0.7mlm/in,蒸发光散射检测器的漂移管温度105℃,载气流速2.8Lm/in。结果线性范围0.9～2.4mgm/l,r=0.9997,平均回收率为103.1%,RSD=1.2%(n=9)。结论本法简便、快速,结果准确可靠,重现性好,可用于磷霉素钙胶囊的质量控制。

Objective To establish an HPLC-ELSD method for the determination of fosfomycin sodium for injection. Method Using Prevail Cls column （4.6mm ×250mm,5μ m）, 0. 25mol/L trifluroacetic acid as the mobile phase. The flow rate was 0. 7ml/min;ELSD： the temperature of the drift tube was set at 105℃ ,and the flow rate of gas was 2. 8L/min. Results The linear/ty range was 0.9 - 2.4 mg/ml, r = 0. 9999. The average recovery was 100. 4%, （RSD = 1.6%, n=9）. Conclusion The method is simple, rapid and reproducible and can be used for quality control of fosfomycin calcium capsules.