摘要
目的建立RP-HPLC测定人血浆中西洛他唑含量,并研究西洛他唑片在健康人体内的药动学.方法色谱柱为HypersilODS-2（4.6 mm×150mm,5 μm）柱,流动相为乙腈-水（45：55）,流速1.0mL·min^-1,柱温35℃,检测波长254 nm.结果西洛他唑在25～2 000μg·L^-1内线性关系良好（r=0.999 2）,血浆最低检测浓度为10μg·L^-1,日内及日间RSD均小于6%,在3种不同浓度下,平均回收率分别为102.71%,102.03%和99.01%.人体药动学研究表明,药-时曲线符合二房室模型,主要药动学参数tmax3.7 h,ρmax749.2μg·L^-1,AUC0～4810088.5μg·h·L^-1,t1/2α2.5 h,t1/2β11.9 h.结论此法简便、灵敏、准确、稳定,可用于药物分析,其药动学参数可为临床合理用药提供理论依据.
OBJECTIVE To establish a reversed phase HPLC method for the detemination of eilustazul in human plasma and Io study its phannacokineties in healthy voluntcers. METHODS A hypersil ODS-2 column（4.6 mm× 150mm, 5μm）was used.The mobile phase consisted of aeetonitrile-water（45：55） with a flow rate of 1.0 mL·min^-1, and Ihe ultraviloet wavelength was at 254 nm. RESULTS The calibration curve was linear over the range of 25 - 2 000μg·L^-1（ r- 0.999 2）and the quantitative limit was 10μg·L^-1. The intra- and inter-assay coeffieient of variation were less than 6% at all levels. The average recoveries were 102.71%, 102.03% and 99.01%, respectively. The plasma concentration-lime course followed a 2-compartment open model and its main pharmacokinetic paramelers were as fullows： tmax3.7 h,ρmax 749.2μg·L^-1 AUC0-48 10088.5μg·L^-1, t1/2α 2.5h, t1/2β 11.9 h. CONCLUSION This method is easy, sensitive, aeeurateand stable and is suitable for the pharamacokinetic study of cilostazol.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2006年第11期848-850,共3页
Chinese Pharmaceutical Journal
