高效液相色谱法测定唑来膦酸中的磷酸盐和亚磷酸盐

Determination of Phosphate and Phosphite in Zoledronic Acid by HPLC

建立了测定唑来膦酸中磷酸盐和亚磷酸盐的高效液相色谱法。以IC-PAK色谱柱为固定相,以体积分数0.07%的甲酸溶液(用1 mol/L氢氧化钠溶液调节pH至3.5)为流动相,采用折光检测器检测唑来膦酸样品。唑来膦酸、磷酸盐和亚磷酸盐3组分分离完全,检测限分别为15,20和15 ng,线性关系良好,相对标准偏差均小于1%。该方法简便、准确,适用于唑来膦酸中磷酸盐和亚磷酸盐的测定。

A new analytical method based on high performance liquid chromatography （HPLC） was obtained for the determination of phosphate and phosphite in zoledronic acid. The chromato- graphic separation of zoledronic acid sample was achieved on an IC-PAK column with a refractive index detector. The mobile phase was composed of 0.07% formic acid and the pH was adjusted to 3.5 with 1 mol/L sodium hydroxide solution. Zoledronic acid, phosphate and phosphite were completely separated and the detection limits were 15 ng, 20 ng and 15 ng respectively. The calibration curves showed good linearity, and the relative standard deviations （RSD） were less than 1%. The method is simple, accurate and suitable for the determination of phosphate and phosphite in zoledronic acid.