高效液相色谱法检测血浆格列吡嗪及其在人体药动学研究中的应用

目的建立人血浆格列吡嗪检测的高效液相色谱方法，用于研究格列吡嗪片的人体药代动力学。方法血浆经乙醚革取，以TC-C18为色谱柱；流动相为乙腈-0．1％三氛乙酸-水体系，流速为1．0mL·min^-1；检测波长274nm。测定12名健康志愿者单剂量口服10mg格列吡嗪片后的血药浓度经时过程。由DAS2．0程序处理计算药动学参数。结果格列吡唪浓度在25～1600μg·L^-1范围内线性关系良好；定量下限为25μg·L^-1；高中低三个浓度的相对回收率分别为（100．75±7．23）％，（102．08±4．29）％和（101．01±1．82）％；日内RSD分别为6．94％，4．68％和1．86％，日同RSD分别为8．05％．5．07％和2．16％。结论本方法简便，快速，准确可靠，适用于人血浆格列吡嗪浓度的测定及其药代动力学研究。

RP-HPLC determination of Glizipide in Human plasma and its pharmacokinetics

Objective To determine glipizide in human plasma by RP-HPLC, and to study its pharmacokinetics in healthy volunteers. Methods The plasma were extracted by ethyl ether. The analytical column was packed with TC-C18. The mobile phase was acetonitrile-0,1% trifluoroacetic acid-water and the flow rate was 1.0mL·min^-1.The UV detection wavelength was 274nm. The pharmacokinetics parameters were obtained with the help of DAS 2.0 system.Results Excellent liner relationship was obtained from the range of 25 μ g· L^-1 to 1600 μ g· L^-1,the limit determination of trimetazidine was 25 μ g· L^-1. The relative recoveries were （100.75 ± 7.23）%,（102.08± 4.29）% and （101.01 ±1.82）% respectively at three concentrations, the intra-day RSD were 6. 94%, 4.68% and 1.86% and inter-day RSD were 8.05%, 5,07% and 2.16% respectively. Conclusion The method is simple, rapid, accurate and can be used to determine the glipizide concentration in human plasma and for study for its pharmacokinetics.