离子色谱法测定依替膦酸二钠及其片剂的含量及有关物质

目的: 建立离子色谱-抑制电导检测法测定依替膦酸二钠及其片剂的含量及有关物质。 方法: 采用IonPac AS11-HC阴离子交换色谱柱分离,30 mmol·L^-1 KOH溶液为淋洗液等度洗脱,抑制电导检测磷酸根、亚磷酸根等有关物质以及依替膦酸二钠的含量。 结果: 依替膦酸二钠在0.0021~0.1243 g·L^-1范围内线性关系良好(r=0.9997),依替膦酸二钠、磷酸和亚磷酸的检出限(S/N＝3)分别为0.66 ng、0.36 ng、0.15 ng,片剂的平均回收率为98.0%(RSD＝0.5%),各杂质与主成分色谱峰能够完全分离。 结论: 该方法准确、灵敏、简便,可用于依替膦酸二钠及其片剂的质量控制。

Objective: To establish an ion chromatography method with suppressed conductivity detection for the determination of Etidronate Disodium and its related substances in Etidronate Disodium and its tablets. Methods: The separation was performed on an Ionpac AS11-HC anion exchange column eluted with 30 mmol L^-1 potassium hydroxide solution at an isocratic elution program.Etidronate Disodium and its related substances such as phosphate,phosphite were determined by suppressed conductivity detection. Results: A good linear relationship was observed in the concentration range of Etidronate Disodium of 0.0021-0.1243 g·L^-1(r=0.9997).The limits of detection were 0.66 ng,0.36 ng,0.15 ng for Etidronate Disodium,phosphate and phosphite.The average recovery of the tablets was 98.0%(RSD＝0.5%).The related substances gained a completely chromatography separation with the principal peak. Conclusion: The method is accurate,sensitive and simple,which provides a new reliable analytical method for the quality control of etidronate disodium and its tablets.

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