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目的建立血浆中阿仑膦酸钠的HPLC-FLD检测方法,并应用于药动学研究。方法采用Kromasil-C18柱(4.6 mm×150 mm,5μm);流动相:甲醇-乙腈-柠檬酸-焦磷酸钠体系;流速:1.5 ml·min-1;柱温:35℃;激发波长:(λex)=260 nm,发射波长:(λem)=310 nm。24名健康男性志愿者单剂量口服阿仑膦酸钠片,测定血浆药物浓度,计算药代动力学参数。结果阿仑膦酸钠在1~100 ng·ml-1范围内线性关系良好(r=0.9999),最低定量限为1 ng·ml-1。阿仑膦酸钠的专属性强,日内、日间精密度和准确度良好。结论本文研究建立了阿仑膦酸钠在血浆中HPLC-FLD的检测方法,该方法灵敏、准确,可用于临床药动学及生物等效性研究。
Objective To establish a HPLC-FLD method for the determination of alendronate in plasma and its application to pharmacokinetic studies. Methods The mobile phase consisted of methanol-acetonitrile-citric acid-sodium pyrophosphate solution at a flow rate of 1.5 ml · min-1 with a Kromasil-C18 column (4.6 mm × 150 mm, 5 μm) λex) = 260 nm, emission wavelength: (λem) = 310 nm. Twenty-four healthy male volunteers received a single oral dose of alendronate tablets, measured plasma drug concentrations, and calculated pharmacokinetic parameters. Results Alendronate sodium had good linearity (r = 0.9999) in the range of 1 ~ 100 ng · ml-1 and the lowest limit of quantification was 1 ng · ml-1. Alendronate sodium has strong specificity and good precision and accuracy in the days and days. Conclusion This study established a method for the determination of alendronate in plasma by HPLC-FLD. The method is sensitive and accurate and can be used in clinical pharmacokinetics and bioequivalence studies.