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目的:建立柱前衍生化高效液相色谱法测定阿仑膦酸钠浓度的方法。方法:阿仑膦酸钠与衍生化试剂芴甲氧羰酰氯反应,生成具有荧光性质的物质,用高效液相色谱-荧光法检测衍生化产物的生成量以计算药物浓度。流动相为有机相和水相组成的混合体系,梯度洗脱,流速为1mL·min-1,柱温为35℃,激发波长和发射波长分别为260、310nm。结果:阿仑膦酸钠检测浓度的线性范围为5.0～200.0ng·mL-1,最低检测限为0.5ng·mL-1,回收率为97.40%～107.88%,日内和日间RSD均<6.95%。结论:该方法操作简便、灵敏度高,可用于生物样品中阿仑膦酸钠浓度的测定和药动学研究。
Objective: To establish a method for the determination of alendronate sodium by precolumn derivatization high performance liquid chromatography. Methods: Sodium alendronate was reacted with fluorenylmethoxycarbonyl chloride to produce a fluorescent substance. The yield of the derivatized product was measured by high performance liquid chromatography-fluorescence method to calculate the drug concentration. The mobile phase consisted of a mixture of organic and aqueous phases with a gradient elution at a flow rate of 1 mL · min-1 and a column temperature of 35 ° C. The excitation and emission wavelengths were 260 and 310 nm, respectively. Results: The linear range of alendronate sodium concentration was 5.0 ~ 200.0 ng · mL-1, the lowest detection limit was 0.5 ng · mL-1, the recovery was 97.40% -107.88%, and the intra-day and interday RSDs were both <6.95 %. Conclusion: The method is simple, sensitive and can be used for the determination of alendronate concentration and pharmacokinetics in biological samples.