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[目的]建立人血浆中麦考酚酸的高效液相色谱定量方法.[方法]色谱柱为安捷伦C18(150.0mm×4.6mm,5μm)色谱柱,流动相为0.05mol/L磷酸钠(pH值为2.88)-乙腈(65∶35),流动速度为1.0mL/min,柱温为30℃,检测波长为240nm,以卡马西平为内标物.[结果]麦考酚酸在0.5～50.0mg/L血药质量浓度范围内时血药质量浓度与峰面积比值呈良好的线性关系(r=0.999 7);低、中、高质量浓度的提取回收率分别为89.77%,99.43%,100.39%,方法回收率分别为102.33%,104.62%,107.39%;日内、日间精密度RSD均小于7%,样品在室温24h内、-20℃冰冻及冻融等条件下稳定性良好.[结论]利用高效液相色谱法测定麦考酚酸的血药质量浓度具有简便、快速、准确、重现性好等特点,可用于临床服用吗替麦考酚酸酯后麦考酚酸血药质量浓度监测及其药物代谢动力学研究.
[Objective] To establish a HPLC method for the determination of mycophenolic acid in human plasma. [Method] The column was Agilent C18 (150.0mm × 4.6mm, 5μm) with a mobile phase of 0.05mol / L sodium phosphate The value of 2.88) -acetonitrile (65:35), the flow rate of 1.0mL / min, the column temperature of 30 ℃, the detection wavelength of 240nm, with carbamazepine as internal standard. [Results] Mycophenolic acid in 0.5 ~ The linear range was 50.0 mg / L (r = 0.999 7). The recoveries of low, medium and high concentration were 89.77% and 99.43% respectively, 100.39% .The recovery rates were 102.33%, 104.62% and 107.39% respectively. The RSDs of intra-day and inter-day precision were all less than 7%, and the stability of the samples was stable within 24h at room temperature, Conclusion] The HPLC method for the determination of plasma concentration of mycophenolic acid is simple, rapid, accurate and reproducible. It can be used clinically for mycophenolate mycophenolate mofetil Quality Monitoring and Pharmacokinetic Studies.