离子色谱法测定帕米膦酸二钠注射液的含量

Determination of pamidronate disodium injection by ion chromatography

目的:采用离子色谱法建立帕米膦酸二钠注射液含量的检测方法。方法:选用DIONEX IonPac AS22(4 mm×250 mm)色谱柱,淋洗液为3 mmol/L草酸溶液,流速为1.2 ml/min,电导检测器。结果:帕米膦酸二钠在0.07～0.92 mg/ml浓度范围内呈良好的线性关系(r=0.9996),其高中低3种浓度的平均回收率分别为99.9%(n=9)。结论:该方法准确、灵敏、简便,可用于帕米膦酸二钠注射液的质量控制。

Objective：To develop an ion chromatography method for determination of pamidronate disodium injection.Methods：The separation was performed on DIONEX IonPac AS22（4 mm×250 mm） column eluted with 3 mmol/L oxalic acid solution at the flow rate of 1.2 ml/min by using conductivity detector.Results：Pamidronate disodium showed good linearity（r=0.9996） in the range of 0.07～0.92 mg/ml,and the average recovery was 99.9%（n=9）.Conclusion：The method is accurate,sensitive and simple.It can be used for the quality control of pamidronate disodium injection.