人血浆中病毒唑浓度的高效液相色谱测定法建立

THE METHOD OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR DETERMINATION OF RIBAVIRIN IN HUMAN PLASMA

目的建立高效液相色谱法测定人血浆中病毒唑的浓度。方法采用液-液提取法处理血浆样品,色谱柱为C18(250mm×4.6mm,5μm),流动相为50mM(pH=3.23)的磷酸缓冲液和乙腈,流速为1.0 ml.min-1,紫外检测波长为235 nm,柱温为25℃。结果血浆中内源性物质对样品测定无干扰。血浆中病毒唑浓度在0.08～10.0μg.ml-1范围内,线性关系良好(r=0.9971),最低定量浓度为0.08μg.ml-1,平均提取回收率为82.3%,日内、日间RSD分别小于7.2%和11%。结论本法简便、快速、准确,适用于病毒唑的血药浓度监测和药代动力学研究。

Objective To establish a High Performance Liquid Chromatography （HPLC） method for the determination of Ribavirin in human plasma. Methods Plasma samples were prepared by liquid/liquid extraction. Ribavirin were separated on a Diamonsil C18 （250mm×4.6 mm,5μm）with the mobile phase consisted of 50mM phosphate buffer（pH =3.23 ） and acetonitrile at a flow rate of 1.0 ml · min-1 at 25℃ ,the detection wavelength was set at 235 nm. Results The blank plasma did not interfere with the determination of ribavirin. There is a good linear relationship within the range of 0.08 - 10.0μg·ml-1 （ r = 0. 9971 ）, The limit of quantitation was 0.08 μg ·m1-1. The average extraction recovery was 82.3 %. The intra - day RSD and inter - day RSD were less than 7.2% and 11% respectively. Conclusion The method is simple, rapid and accurate. It is suitable for the therapeutic drug monitoring and the pharmacokinetic study of Ribavirin.