反相高效液相法测定盐酸二甲双胍的血药浓度

Determination of metformin hydrochloride in serum by RP -HPLC

目的建立一种快速、准确、稳定测定人血清中盐酸二甲双胍浓度的方法。方法取0．2mL血清样品，用0．5mL乙腈沉淀蛋白，振摇，离心，取上清液加2mL三氯甲烷，振摇，离心，再取上清液40μL进样分析。色谱柱为Diamosil-C18柱（250mm×4．6mm，5μm），柱温室温，流动相：0．005mol·L^-1十二基硫酸钠（SDS，含0．5％三乙胺，用冰醋酸调pH4．0）-乙腈（60：40），流速1．0mL·min^-1，紫外检测器，检测波长为233nm。结果盐酸二甲双胍的线性范围为3．00～100．00μg·mL^-1，回归方程：C=6．47×10—5A-0．5003（r=-0．9999），范围内线性关系良好。日内、日间精密度（RSD）小于4％。结论本法操作简便，快捷，稳定，重复性好。

Objective To establish RP-HPLC method for determination of drug concentration of metformin hydrochloride in human serum. Methods There 0.2mL serum sample was deproteinated with 0.5mL acetonitrile and purified with 2mL trichloromethane. Mefformin was analyzed on Diamosil C18 column （4.6mm×250mm,5μm） and detected at 233 nm at room temperature. The mobile phase was composed of 0.005 mol ·L^-1 SDS （containing 0.5% triethanolamine,adjusted by glacial acetic acid c to pH 4.0） -acetonitrile （60：40）. Flow rate was 1.0mL·min^-1. Results The linear range was 3.00 to 100.00μgomL-1 and regression equation： C=6.47×10-5A-0.5003 （r=0.9999）. The precision within-day and between-day precision （RSD） was very good （〈4%）. Conclusion The method is simple,sensitive,specific and reproducible.