RP-HPLC测定盐酸二甲双胍的血药浓度

Determination of Metformin Hydrochloride Concentration in Body Fluids By RP-HPLC

目的建立用反相高效液相色谱法(RP-HPLC)测定人血浆样品中二甲双胍浓度的定量方法.方法应用Agilent1100系列高效液相色谱仪,Agilent Zorbax SB-C18色谱柱(5μm,150mm×4.6mm),流动相为0.01mol·L-1十二烷基硫酸钠-乙腈(63∶37,pH＝4.0);检测波长233nm,流速1.0ml/min.结果盐酸二甲双胍浓度在0.06～4μg·ml-1范围内呈良好的线性关系(r=0.9997),平均回收率为(98.92±1.11)%,RSD为2.47%.结论 RP-HPLC法简便、快捷、灵敏、准确,适用于临床药代动力学及药效学的研究.

Aim An RP-HPLC method was establisted for assaying mefformin hydrochloride in human plasma.Methed Mefformin hydrochloride in the samples was quantitatively analyzed by HPLC without the internal standard. HPLC conditions for mefformin hydrochloride were as follows： Agilent1100 HPLC instmmengt was used with a C18 eolumn（5μm, 150mm - 4.6mm）. The mobile phase consisted of 0.01% sodium dodecyl sulphate-Aeetouitrile （63 ： 37, pH = 4.0） in plasma with the flow rate 1.0ml/min. They were determined at UV wavelength of 233nm. Results The linear range was 0.06 - 4μg·ml^- 1 of metformin hydrochloride concentration（ r = 0.9997）. The average recovery was （98.92 ± 1.11 ） %, and RSD was 2.47 %. Conclusion RP-HPLC was simple, rapid, accurate, and suited to the clinical study on pharmacokinefies and pharmaeodynamics of mefformin hydrochloride.