RP-HPLC法检测人血浆盐酸二甲双胍浓度

目的:建立人血浆盐酸二甲双胍检测的反相高效液相色谱方法。方法:血浆高氯酸沉淀,以ZORBAX SB-C₁₈为色谱柱;流动相为乙腈-0.1%三氟乙酸-10mmol·L^-1SDS-水体系,流速为1.0ml·min^-1;检测波长234nm。结果:盐酸二甲双胍浓度在0.05～6.00mg·L^-1范围内线性关系良好（r=0.9999）,低中高三个浓度(0.10、1.00、4.00mg·L^-1)的相对回收率分别为（94.77±2.49）%、（99.71±3.79）%和（97.24±2.09）%;日内RSD分别为5.41%、4.42%和2.32%,日间RSD分别为6.03%、4.15%和2.49%。结论:本方法简便、快速、准确可靠,适用于人血浆盐酸二甲双胍浓度的测定及其药物动力学研究。

Determination of Metformin Hydrochloride in Human Plasma by RP-HPLC

To develop an RP-HPLC method for the determination of metformin hydrochloride in human plasma. Metllod ： The human plasma samples were precipitated by perchloric acid. The analytical column was packed with ZORBAX SB-CIs. The mobile phase was acetonitrile-10 mmol· L^-1 SDS-0. 1% trifluoroacetic acid-water and the flow rate was 1.0 ml· min^-1. The UV detection wavelength was 234 nm. Result： Excellent linear relationship was obtained within the range of 0.05-6. 00mg· L^- 1 （r = 0. 999 9）. The relative recoveries were （94. 77 ± 2. 49 ） % , （ 99. 71 ± 3.79 ） % and （ 97. 24 ± 2. 09 ） % for three concentrations with the intra-day RSD of 5.41% ,4. 42% and 2. 32% ,and inter-day RSD of 6.03% ,4. 15% and 2.49% ,respectively. Conclusion： The method is simple, rapid and accurate, and could be used to determine the concentration of mefformin hydrochloride in human plasma and study its pharma cokinetics.