反相高效液相色谱法测定人血清中西洛他唑质量浓度

Determination of Cilostazol in Human Serum by RP-HPLC

目的建立测定人血清中西洛他唑质量浓度的反相高效液相色谱(RP-HPLC)法。方法采用液-液萃取高效液相色谱紫外检测法,以地西泮为内标,色谱柱为Phenomenex Synergi 4u Fusion-RPC18柱(250mm×4.6mm,5μm),流动相为乙腈-水(45∶55),流速1.0mL/min,检测波长258nm。结果血清中内源性物质不干扰西洛他唑的检测,西洛他唑质量浓度的线性范围为0.016～2.000μg/mL,日内、日间精密度的RSD均小于15%,低、中、高质量浓度(0.031,0.250,1.000μg/mL)溶液的平均提取回收率分别为76.8%,78.5%,77.1%。结论RP-HPLC法快速、简单、准确,符合生物样品检测要求,可用于临床药代动力学研究。

Objective To develop a rapid, simple and specific HPLC method for determination of cilostazol in human serum. Methods RP- HPLC was used. The analyte and diazapam, used as the internal standard, were analyzed on the Phenomenex Synergi 4u Fusion- RP C18 （250 mm × 4.6 mm, 5 μm） column at the wavelength of 258 nm after liquid - liquid extraction. Acetonitrile - water （45 ： 55, V/ V） was used as the isocratic mobile phase at a flow rate of 1.0 mL/min. Results The assay was linear over the concentration range of 0.016- 2.000 μg/mL excluded from endogenous substance effect. RSD for the intra- day and inter- day precision over the entire concentration range was less than 15%. The mean extraction recovery rates of cilostazol were 76. 8%, 78.5%, 77.1% at the concentrations of 0. 031, 0. 250, 1. 000 μg/mL, respectively. Conclusion This RP-HPLC method is simple, rapid and specific to determine cilostazol in human serum for clinical pharmacokinetics.