摘要
目的:建立人血浆中利托那韦的含量测定方法,用于其血药浓度测定并进行临床药代动力学研究。方法:采用反相高效液相色谱-二极管阵列检测器分离测定血浆中的利托那韦浓度。色谱条件:Hypersil C_(18)柱(4.6mm×200mm,5μm),流动相为0.05mol·L^(-1)的磷酸盐缓冲液(pH=5.6)-乙腈(50:50);流速为1.0mL·min^(-1),利托那韦的检测波长为210nm。9例健康志愿者单剂量口服600mg 利托那韦口服液,用高效液相色谱法测定给药后不同时间点血浆中利托那韦的浓度,计算其药动学参数。结果:利托那韦在0.078～40.0μg·mL^(-1)浓度范围内呈良好的线性,最低检测浓度为0.02μg·mL^(-1)。低、中、高浓度的方法回收率分别为90.65%,98.60%,100.1%,RSD 均小于5%。健康人体药动学研究证明,利托那韦的药-时曲线符合一室模型。结论:本方法灵敏度高、专属性强、准确、简便,适用于利托那韦的人体药代动力学研究。
Objective：To establish an RP - HPLC method for the determination of ritonavir in human plasma and application of pharmacokinetic study of ritonavir in 9 healthy volunteer. Methods ： RP - HPLC method was used. The separation was carried out using Hypersil C18 （4. 6 mm × 200 mm ,5 μm ） column with mobile phase of 0.05 mol · L^-1 phosphate buffer（pH 5.6） - acetonitrile（50： 50）. The flow rate was 1 mL ·min^-1. The detection wavelength for ritonavir was 210 nm. A single oral dose 600 mg of ritonavir was given to 9 healthy male. Results：The linear range for ritonavir was 0. 078 - 40.0 μg · mL^-1 （ r = 0. 9999 ）. The limit of detection for ritonavir was 0. 02 μg · mL^-1. The relative recoveries were 90. 65% ,98.60% and 100. 1% ,and RSD for intra -day and inter - day were both less than 5%. The pharmacokinetic analysis of ritonavir was studied. It was found to be fitted to a one - compartment model. Conclusion：The method is sensitive, accurate and simple, and suitable for the study on pharmaco- kinetic of ritonavir in body.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2006年第10期1434-1436,共3页
Chinese Journal of Pharmaceutical Analysis
