RP-HPLC法测定人体血浆中雷贝拉唑钠的含量

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（250mm×4．6mm，5μm），0．1mol／L醋酸铵缓冲液（0．1mol／LNaOH调pH7．81）-乙腈（72：28）为流动相，检测波长284nm，流速1．5mL／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5～1600ng／mlL（r=0．9999），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.

Determination of rabeprazole sodium in human plasma by RP-HPLC

Objective： To develop a RP-HPLC method for determination of the rabeprazole sodium in human plasma. Methods： The ehromatographic separation was can＇ied out on Dikma Diamonsil C18 column （4. 6 mm × 250 mm,5 μm） , the mobile phase was 0. 1 mol/L ammonium acetate buffer （ pH adjusted to 7.81 with sodium hydroxide solution）- acetonitrile （72 ： 28） and the flow rate was 1.5 mL/min with UV detection（284 ran）. After extraetion 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% , respeetrely. 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.