摘要:
目的:建立测定人体血浆中雷贝拉唑钠浓度的高效液相色谱法。方法:色谱条件:Dikma Diamonsil C18分析柱(250 mm×4.6 mm,5μm),0.1 mol/L醋酸铵缓冲液(0.1 mol/LNaOH调pH7.81)-乙腈(72:28)为流动相,检测波长284 nm,流速1.5 mL/min。血浆样品经乙酸乙酯萃取一次,40℃氮气挥干后进样。结果:雷贝拉唑钠血药浓度的线性范围为5～1 600 ng/mlL(r=0.999 9),提取回收率78.45%～89.56%,方法回收率95.16%～97.52%,日内、日间RSD分别为6.52%和8.23%。结论:该方法灵敏、准确、专一、简便,适于雷贝拉唑钠肠溶片的人体药动学和生物等效性研究。
Abstract:
Objective : To develop a RP-HPLC method for determination of the rabeprazole sodium in human plasma. Methods : The chromatographic separation was carried out on Dikma Diamonsil C18 column(4.6 mm×250 mm,5μm),the mobile phase was 0.1 mol/L ammonium acetate buffer(pH adjusted to 7.81 with sodium hydroxide solution)-acetonitrile(7228) and the flow rate was 1.5 mL/min with UV detection(284 nm).After extraction once from plasma with ethyl acetate,RPZ was evaporated to dryness at 40 ℃ under a nitrogen stream. Results :The linear range was 5～1 600 ng/mL,r=0.999 1.The extraction recovery of raberazole was78.45 %～89.56 %,recovery of the method was within 95.16 %～97.52 %,and within-day and between-day RSD 6.25% and 8.23%,respectrely. Conclusion :The method is sensitive,specific and reproducible for the determination of rabeprazole sodium concentration in human plasma.It is very suitable for pharmacokinetics study of rabeprazole.
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