HPLC-UV法用于人血浆中罗红霉素的浓度测定及药代动力学和生物等效性研究

HPLC-UV Method for Determination Concentration of the Roxithromycin in the Human Plasma and Study of Pharmacokinetic and Bioequivalence

目的建立HPLC-UV法测定人血浆中罗红霉素的方法，并探讨罗红霉素的药代动力学和生物等效性。方法采用Diamonsil C18柱（150mm×4．6mm，5μm），流动相为乙腈：0．01mool磷酸二氢铵=39：61（v／v），流速1mL／min；以卡马西平为内标，检测波长为210nm。血浆样品用正己烷（含5％的异丙醇）液-液萃取后经C18分离。结果罗红霉素在0．25～16．0mg／L线性关系良好，r=0．999，最低检测限为0．25mg／L。萃取回收率〉70％，方法回收率99．8％～110．5％，批内、批间精密度均〈15％。结论HPLC—UV方法结果准确、灵敏度高，适用于罗红霉素药代动力学和生物等效性研究。

Objective To establish a HPLC-UV method for the determination of roxithromycin in the human plasma and to explore the pharmaeokinetics and bioequivalence of roxithromycin. Methods The analytes were determined by HPLC-UV method using C18 column（150 mm × 4. 6 mm,5μm） ,Roxithromycin was separated on a C18 column with a mobile phase consisting of acetonitrile.0. 01 mol ammonium dihydrogen phosphate（39 ： 61, v/v）, and the flow rate was 1 mL/min. Carbamazepine was used as the internal standard and the wavelength was detected at 210 nm. Roxithromycin was extracted from the plasma sample with N-hexane（including 5% dehydrated alcohol）. Results The calibration curve was linear within 0. 25 - 16. 0 mg/L （r=0. 999）. The limit of quantitation was 0.25 mg/L. The extraction recovery was〉70% and the method recovery was 99.8 %-110.5 % . The relative standard deviations for the intra-day and inter-day were〈15%. Conclusion The method is HPLC-UV, accurate, rapid and suitable for the pharmacokinetics and bioequiavailability study of roxithromycin.