高效液相色谱法测定磷霉素氨丁三醇散中磷霉素氨丁三醇的含量

摘要

Objective:To establish an high performance liqulid chromatography( HPLC) method for content determination of fosfomy-cin trometamol in fosfomycin trometamol powder.Methods: The analysis was performed on Zorbax NH2 (250 mm ×4.6 mm, 5 μm) column, which was held at a constant temperature of 35 ℃, using a mobile phase consisted of 10.89 g・L-1 potassium dihydrogen phos-phate solution at a flow rate of 1.0 mL・min-1 , injection volume 5μL, refractive index detector( RID) temperature was set as 35℃.Re-sults:There was a good linear relationship for fosfomycin trometamol in the range of 36.0~180.0 mg・mL-1 .The average recovery rate was 99.59%and the RSD was 0.24%.Conclusion:This method is simple, sensitive and accurate.It can be used for determination of fosfomycin trometamol powder.%目的：建立测定磷霉素氨丁三醇散中磷霉素氨丁三醇含量的高效液相色谱法。方法：高效液相色谱柱为Zorbax NH2柱（250 mm ×4.6 mm，5μm），柱温为35℃，流动相为10.89 g・L-1磷酸二氢钾水溶液，流速为1.0 mL・min-1，进样量为5μL，示差折光检测器，温度为35℃。结果：磷霉素氨丁三醇浓度在36.0～180.0 mg・mL-1范围内与峰面积呈现良好线性关系（ r ＝0.9999），平均回收率为99.59％（RSD＝0.24％）。结论：该方法操作简便、灵敏、准确，适用于磷霉素氨丁三醇散的含量测定。