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目的:建立高效液相色谱分析亲脂性阿仑膦酸酰胺化衍生物的方法。方法:采用反相离子对色谱法、示差折光检测器,以Agilent CLC-ODS C18为固定相,流动相为甲醇-水(含5mmol·L-1磷酸二氢铵,2mmol·L-1十二烷三丁基溴化胺,pH7.2),两者比例为75∶25,等度洗脱,流速1.0mL·min-1。结果:衍生物与其他物质分离良好,方法在0.5～30mg·mL-1内线性关系良好(r=0.9994),回收率为98.3%,RSD=0.4%(n=6)。结论:该方法操作简单方便,重复性较好,结果令人满意,可用于阿仑膦酸钠衍生物的分析。
Objective: To establish a method for the analysis of lipophilic alendronate amidated derivatives by high performance liquid chromatography. Methods: Reversed-phase ion pair chromatography and differential refractive detector were used. The mobile phase was Agilent CLC-ODS C18 with methanol-water (containing 5 mmol·L -1 ammonium dihydrogen phosphate, 2 mmol·L -1 Twelve Alkane tributyl amine bromide, pH7.2), the ratio between the two was 75:25, isocratic elution, flow rate 1.0mL · min-1. Results: The derivatives were well separated from other substances. The method showed a good linearity (r = 0.9994) within 0.5-30 mg · mL-1 with a recovery of 98.3% and a RSD of 0.4% (n = 6). Conclusion: The method is simple and convenient to operate with good reproducibility and satisfactory results. It can be used in the analysis of alendronate derivatives.