摘要
目的 建立曲马多血药浓度的高效液相色谱-质谱测定法,用于人体药动学研究。方法 血浆样品用饱和碳酸氢钠碱化,用乙酸乙酯提取。采用AgilentZorbaxSB C18(15 .0mm×2 . 1mm ,5 μm)柱,以甲醇-水(含1%甲酸) =8∶14 (V/V)为流动相,内标为盐酸非洛普,检测离子为m/z 36 4 . 5 (曲马多)、m/z344 . 5 (内标) ,裂解电压为12 0V。测定了2 0名受试者单剂量口服曲马多10 0mg后血药浓度。结果 最低检测限达0 . 5 μg·L-1,线性范围1～5. 0 0 μg·L-1(r =0 . 9996 ,n =5 ) ,日内和日间RSD均<10 % ,方法回收率为94 .2 %～10 .9 7% ,符合生物样品分析要求。结论 本法准确、快速、灵敏,适合曲马多的人体药动学研究。
AIM To establish a HPLC-MS method for investigating the pharmacokinetics of tramadol in human plasma. METHODS The plasma was treated with NaHCO 3, then extracted with ethyl acetate. The HPLC-MS method was performed with an Agilent Zorbax SB-C 18 column (150 mm×2.1 mm,5 μm),and the mobile phase was methanol-water(1% formic acid)(86∶14,V/V).RESULTS The standard curve was linear in the range of 1-500 μg·L -1 (r=0.9996,n=5).The intra-day and inter-day RSD were all less than 10%.The method recovery was more than 94%.The low limit concentration was 0.5 μg·L -1.The plasma concentration of 20 healthy subjects was detected.CONCLUSION The assay method is accuracy,quick,sensitive and applicable for pharmacokinetic study of tramadol.
出处
《中国临床药学杂志》
CAS
2005年第1期38-40,共3页
Chinese Journal of Clinical Pharmacy
