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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-C_(18)为色谱柱;流动相为乙腈-0.1%三氟乙酸-10mmol·L~(-1)SDS-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。
Objective: To establish a method for the determination of metformin hydrochloride in human plasma by reversed-phase high performance liquid chromatography. METHODS: Plasma perchloric acid was precipitated by ZORBAX SB-C 18 column. The mobile phase consisted of acetonitrile-0.1% trifluoroacetic acid-10 mmol·L -1 SDS-water at a flow rate of 1.0 ml · min ~ (-1); detection wavelength 234nm. Results: The concentration of metformin hydrochloride in the range of 0.05-6.00 mg · L -1 was good (r = 0.9999), and the concentration of metformin hydrochloride was 0.10%, 1.00% and 4.00 mg · L -1, respectively The mean daily RSD were 5.41%, 4.42% and 2.32%, respectively. The daytime RSDs were 6.03%, 4.15% and 2.49%, respectively, and the recovery rates were (94.77 ± 2.49)%, (99.71 ± 3.79)% and (97.24 ± 2.09) %. Conclusion: The method is simple, rapid, accurate and reliable and is suitable for the determination of the concentration of metformin hydrochloride in human plasma and its pharmacokinetics.