高效液相色谱法测定人血清及尿中奥拉西坦的浓度

以阿昔洛韦(acyclovir)为内标,NH2柱为分析柱;乙腈:水(80:20,v/v)为流动相,检测波长为210nm,建立了测定人血清及尿中奥拉西坦(oxiracetam)浓度的HPLC方法。奥拉西坦和内标保留时间分别为6.3min和8.1min;二峰分离良好。本法平均回收率:血清99.7±5.9%;尿99.0±5.6%,日内及日间相对标准偏差(RSD)为5.0～10.9%,血清及尿标准曲线相关良好,最低检测浓度血清为1μg·mL^-1,尿为20μg·mL^-1。本方法操作简便,迅速,灵敏,可靠。可以满足临床药代动力学测试的要求。

METHODOLOGICAL STUDY ON THE DETERMINATION OF OXIRACETAM CONCENTRATION IN SERUM AND URINE BY HPLC

A method was developed for the determination of oxiracetam concentration in serum and urine by HPLC. Acyclovir was used as an internal standard.The analytical column was a stainless-steel column(3 0 mm×4.6 mm ID ) filled with 10 μm Bondapak NH2.A mixture of acetonitrile and water(80 :20)as mobile phase was used at a flow rate of l ml·min^-1.Detection was performed at 210 nm. The retention times were 6.3 min for oxiracetam and 8.1 min for the internal standard.The lower detection limits were 1μg· mL^-1 for serum and 20μg· mL^-1 for urine. The precision and accuracy within-day and day-to-day for both serum and urine samples ranged from 5.0 to 10.7%. The mean recoveries were 99.7±5.9% and 99.0±5.6% for human serum and urine ,respectively.The results showed that the method is simple,rapid ,sensitive ,reliable and good enough to be used in studying the clinical parmacokinetics of oxiracetam.