高效液相色谱法测定血浆中西洛他唑浓度及药动学

The determination of cilostazol plasma levels and pharmacokinetics using HPLC

目的:建立测定血浆中西洛他唑浓度的高效液相色谱法,考察西洛他唑在中国健康志愿者体内的药动学行为.方法:血浆样品经液-液提取后,进行色谱分离测定.结果:西洛他唑的最低定量浓度为25.0μg·L-1,线性范围为25.0～2000.0μg·L-1,精密度与准确度符合生物样品分析要求.结论:该法操作简便、快速、灵敏度高.可检测出健康志愿者口服100 mg西洛他唑72 h后的血浆浓度,适于临床药动学研究.

OBJECTIVE A rapid and sensitive HPLC method for the analysis of cilostazol in plasma was developed and the pharmacokinetics of cilostazol in China healthy volunteers was studied. METHODS Plasma samples containing cilostazol and midazolam (internal standard, IS ) were extracted with liquid-liquid extraction, followed by liquid chromatographic separation and determination. RESULTS The limits of quantitation of method for cilostazol was 25.0 μg·L -1 , the calibration curves in plasma was linear in the range of 25.0 to 2 000.0 μg·L -1 and intra and inter-day precision over this range were less than 11.4% . CONCLUSION The method is shown to be accurate, robust and convenient, and suitable for clinical pharmacokinetics study.