HPLC法测定肾移植患者血浆中霉酚酸的浓度

目的:建立以高效液相色谱法测定霉酚酸血药浓度的方法,并研究其在中国肾移植患者体内的多剂量药动学特征。方法:血浆采用乙腈蛋白沉淀后进样。其中,色谱柱为Diamonsil C18,流动相为乙腈-10mmol·L-1KH2PO4(5∶6),流速为1.1mL·min-1,检测波长为254nm,柱温为40℃。此方法应用于测定12例肾移植患者的多剂量药动学。结果:色谱中霉酚酸与内标分离良好,血浆中的内源性杂质无干扰。霉酚酸检测浓度在0.38~59.00μg·mL-1范围内线性关系良好,最低检测限为0.38μg·mL-1;回收率为89.32%~97.63%,日内、日间RSD均<8.00%。药动学结果显示患者服用霉酚酸酯后,霉酚酸的药动学个体差异较大,与文献报道基本一致。结论:本方法结果准确,操作简便,适合于霉酚酸的药动学研究。

Determination of Mycophenolic Acid in Kidney Transplantation Patients by HPLC

OBJECTIVE： To determine the plasma mycophenolic acid concentration by HPLC, and study the multidoses pharmacokinetics character of mycophenolic acid in Chinese kidney transplantation patients. METHODS： The samples were precipitated with acetonitrile before injection. Diamonsil C18 column was used. The mobile phase consisted of acetonitrile- 10 mmol · L^ -1KH2PO4 （5 ： 6） at a flow rate of 1.1 mL · min^-1. The detection wavelength was 254 nm and the column temperature was 40 ℃. This method was used to determine the multidoses pharmacokinetics in 12 kidney transplantation patients. RESULTS. MPA was well - separated from internal standard in chromatography, and endogenous foreign substance in plasma had no interference on the determination. The liner range for MPA was 0.38-59.00 μg·mL^-1, and the lowest detectable concentration of MPA was 0.38 μg·mL^-1. The recovery rate stood at 89.32%- 97.63% ; Both intra -day and inter- day RSD were less than 8.00%. Significant individual difference was noted among the patients treated with MMF in pharmacokinetic results, which was in line with the literature. CONCLUSION： This method is accurate and simple and applicable for the pharmacokinetics study of mycophenolic acid.