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目的:建立高效液相色谱法测定血浆中非诺贝特活性代谢产物非诺贝特酸浓度。方法:以甲醇直接沉淀血浆蛋白,色谱柱为Waters sunfire C_(18)柱(150mm×4.6mm,5μm),流动相为0.05 mol·L~(-1)磷酸二氢钾溶液-甲醇(70:30),用磷酸调pH 2.5,检测波长286nm。结果:非诺贝酸的保留时间约为6.7 min,线性范围为0.2～20.0μg·ml~(-1)(r=0.999 9),最低定量限为0.2μg·ml~(-1),方法回收率99.28%～101.38%,提取回收率97.18%～107.28%,日内和日间RSD均小于10%。结论:本法简便、快捷、灵敏,适用于非诺贝特药物动力学研究。
OBJECTIVE: To establish a HPLC method for the determination of fenofibrate acid concentration in fenofibrate, an active metabolite of fenofibrate in plasma. Methods: The plasma protein was directly precipitated with methanol. The column was Waters sunfire C 18 column (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.05 mol·L -1 potassium dihydrogen phosphate solution (70: 30), pH adjusted to 2.5 with phosphoric acid, detection wavelength 286nm. Results: The retention time of fenofibrate was about 6.7 min with a linear range of 0.2-20.0 μg · ml -1 (r = 0.999 9) and the lowest limit of quantification was 0.2 μg · ml -1. Methods The recoveries ranged from 99.28% to 101.38%. The recoveries ranged from 97.18% to 107.28%. The RSDs were less than 10% during the day and day. Conclusion: This method is simple, rapid and sensitive, suitable for fenofibrate pharmacokinetic studies.