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

RP-HPLC Determination of Glizipide in Human plasma and its Pharmacokinetics

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。方法血浆经乙醚萃取,以TC-C18为色谱柱;流动相为乙腈-0.1%三氟乙酸-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。结果格列吡嗪浓度在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%,日间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。

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.