高效液相色谱法测定早期肾移植患者麦考酚酸的血药浓度

HPLC determination of mycophenolic acid in serum of early period of renal transplant patients

目的建立高效液相色谱法测定人血浆中麦考酚酸浓度的简便方法。方法采用高效液相色谱法,色谱柱为C18柱(3.9 mm×300 mm),以40 mmoL/L四丁基溴化铵-乙腈[55∶45(V∶V),H3PO4调pH=4]为流动相,流速0.8mL/min,紫外检测波长254 nm,用甲醇沉淀蛋白法进行血样处理。结果麦考酚酸的线性范围为0.8～51.54 mg/L(r=0.999 8),平均相对回收率95.5%～109.2%,提取回收率>90%,批内和批间RSD<10%。结论本方法准确、简便,可用于麦考酚酸的血药浓度监测和生物等效性研究。

Objective To establish a high-performance liquid chromatography method for determination of mycophenolic acid in human plasma. Methods The method was performed with C18 column （3.9 mm× 300 mm）. The mobile phase consisted of 40 mmoL/L TBA solution-acetonitrile adjusted to pH 4 with orthophosphoric acid （55 ： 45, V ： V）, with a flow rate 0.8 mL/min. The UV detection wavelength was 254 nm. Plasma samples were extracted with methanol. Results The linear concentration of the calibration curve ranged from 0. 8 to 51.45 mg/L （ r = 0. 9998）. The relative recoveries were between 95.5 % and 109.2%, and the extraction recoveries were more than 90%. Relative standard deviation （RSD） of intraday and interday assays were both less than 10%. Conclusion The method is proved to be reliable and simple for monitoring mycophenolic acid in human plasma and bioequivalence research.