高效液相色谱法测定人体血浆中咪唑立宾及其药动学研究

Determination of mizoribine in human plasma by high performance liquid chromatography and its pharmacokinetics study

目的：建立测定人体血浆中咪唑立宾高效液相色谱法．并测定健康志愿者口服咪唑立宾片12h内血药浓度。方法：采用10％三氯醋酸直接沉淀提取血浆，氨基柱为固定相，乙腈-水-冰醋酸（30：70：0．3）为流动相，在280nm处测定。结果：咪唑立宾本法线性范围为0．1～10mg·L^-1（r=0．9999,n=7）。最低检测限0．02mg·L^-1。低、中、高3种浓度的平均回收率分剐为（90．90±2．01）%,（100．18±0．46）％，（102．32±0．22）％．日内、日间精密度RSD均小于5％。结论：本检测方法简便、快速、经济、准确，可用于测定人血浆中咪唑立宾的浓度。

OBJECTIVE To establish an HPLC method for the determination of rnizoribine in human plasma, and to deter mine the concentration of mizoribine in human plasma after oral administration of mizoribine tablets into healthy volunteers within 12 hours. METHODS The mizoribine was extracted from plasma by 10% trichloroacetic acid. Chromatographic separation was achieved on NH2 cohumn with acetonitrile-H2O-glacial acetic acid（30： 70：0. 3）as the mobile phase. The detection wavelength was 280 nm. RESULTS The linear range was 0. 1 -10 mg·L^ -1 （r= 0. 9999,n = 7）. The detection limit was 0. 02 mg· L^-1. The average recovery of low, middle and high concentrations was （911. 9 ± 2. 0）%, （ 100. 2 ± 0. 5） % and（ 102.32 ± 0. 22） %, respectively. RSDs of inter and intra-day precision were less than 5 %. CONCLUSION The method is simple and accurate for determination of mizoribine in human plasma.