复方二甲双胍片中二甲双胍人体血药浓度测定

Determination of metformin in human plasma by HPLC

目的：建立高效液相色谱（HPLC）法测定复方二甲双胍片中二甲双胍的血药浓度。方法：血浆样品采用氢氧化钠碱化，用氯仿分2次萃取，色谱柱为Sphericorb NH2分析柱（150mm×4．6mm），流动相为0．01mol·L^-1磷酸盐缓冲液-甲醇-乙腈（30：15：55）；流速1．2mL·min^-1，检测波长235nm。结果：二甲双胍定量线性范围0．02～3．046mg·L^-1，绝对回收率大于80％，方法回收率99．92％～105．29％，日内、日间精密度RSD小于8．27％。结论：该方法简便，准确，重复性好，可用于复方二甲双胍的体内药动学研究。

OBJECTIVE An HPI.C method was established for the separation and determination of metformin in compound metformin tablets in human plasma.METHODS The procedure involved basification of plasma and a single solvvent extraction of drug from plasma into chloroform. Sphericorb NH2 column and detected at 235 nm, the mobile phase was NH4H2PO4 buffer-methanol-acetonitrile （30：15：55） used at a flow rate of 1.2 mL·min^-1. RESULTS The calibration curve of metformin was linear in the range of 0. 02-3. 046 mg· L^-1 , the extraction recoveries were more than 80% and the method recoveries were 99. 92%-105.29%,the inter-day and intra-day RSD was less than 8. 27%. CONCLUSION The method was simple, accurate, reproducible and applicable the pharmacokinetics research of metformin.