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目的:建立一种快速、简单的测定大鼠血浆中阿德福韦酯水解产物阿德福韦单特戊酸甲基酯和阿德福韦的离子对反相高效液相色谱方法。方法:用HypersilODSC18反相柱,乙腈50mmol/L醋酸铵缓冲液(2∶98和50∶50)为流动相,采用梯度洗脱,流速1.0ml/min,紫外检测波长为262nm。结果:测定血浆中阿德福韦浓度的线性范围为1.25～60.0μg/ml(r=0.9999),最低检测限为0.40μg/ml(S/N>3),绝对回收率为76.72%～80.61%。结论:本方法准确,灵敏度较高,重复性好,适于对阿德福韦酯结构类似物进行体外血浆稳定性评估筛选,并可为临床前/临床药代研究提供重要的方法学参考。
OBJECTIVE: To establish a rapid and simple method for the determination of adefovir dipivoxil monomethyl ester and adefovir dipivoxil in plasma of rat plasma by RP-HPLC method. Methods: Hypersil ODSC18 reversed-phase column and acetonitrile 50mmol / L ammonium acetate buffer (2:98 and 50:50) were used as the mobile phase. The gradient elution was carried out at a flow rate of 1.0ml / min. The UV detection wavelength was 262nm. Results: The linear range of determination of adefovir in plasma was 1.25-60.0μg / ml (r = 0.9999), the lowest detection limit was 0.40μg / ml (S / N> 3), and the absolute recovery was 76.72% ~ 80.61 %. Conclusion: The method is accurate, sensitive and reproducible. It is suitable for in vitro plasma stability assessment of adefovir dipivoxil analogues and provides an important methodological reference for preclinical / clinical pharmacokinetic studies.