离子色谱法测定伊班膦酸钠注射液中的亚磷酸根和磷酸根的含量

Determination of phosphate and phosphite in ibandronate sodium injection by ion chromatography

目的建立伊班膦酸钠注射液中亚磷酸根、磷酸根的离子色谱分析方法。方法采用IonPacAS11阴离子交换色谱柱,利用在线淋洗液发生器自动产生氢氧化钾梯度淋洗液,以自动再生抑制型电导检测。结果该方法具有较高的灵敏度和良好的线性关系。磷酸根的检测限质量浓度为2.2μg.L-1,线性范围为6.61～496μg.L-1,r=0.999 5;亚磷酸根的检测限质量浓度为0.8μg.L-1,线性范围为2.39～179μg.L-1,r=1.0。结论采用该方法测定伊班膦酸钠注射液中的亚磷酸根和磷酸根,所得结果令人满意。

Objective To develop an assay method for phosphate and phosphite by using ion chromatography.Methods IonPac AS11 was used as ion exchange column.The analysis was conducted with eluent generator that automatically generates potassium hydroxide as the mobile phase and suppresser conductivity.Results The method exhibits excellent sensitivity and good linearity.The detected limit was 2.2 μg · L-1 and 0.8 μg · L-1 for phosphate and phosphite,respectively;while the liner ranges for phosphate and phosphite were 6.6l-496 μg · L-1（r=0.999 5）and 2.39-179 μg · L-1（r=1.0）,respectively.Conclusion The method is proved to be satisfactory for determination of phosphate and phosphite in ibandronate sodium injection.