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目的:建立HPLC法测定人血浆中的盐酸二甲双胍浓度。方法:血浆在酸性条件下以乙腈沉淀蛋白后,用二氯甲烷萃取纯化,以甲醇-5mmol·L-1磷酸盐缓冲液(pH6.6)(51:49,每100ml中含SDS0.1g)为流动相,色谱柱为HypersilODSC18柱(5μm,4.6mm×150mm),检测波长为234nm,柱温40℃。结果:线性范围为125-5000ng·ml-1,最低检测限为20ng·ml-1。低、中、高3种浓度的方法回收率分别为105.76%,93.60%和91.89%。日内、日间RSD均小于5%。结论:该法简便、准确、灵敏,可用于盐酸二甲双胍生物利用度和药物动力学研究。
Objective: To establish a HPLC method for the determination of metformin hydrochloride in human plasma. Methods: After the protein was precipitated by acetonitrile in acidic condition, the plasma was extracted with dichloromethane and purified with methanol-5mmol·L-1 phosphate buffer (pH6.6) (51:49, containing 0.1g of SDS per 100ml) As mobile phase, the column was Hypersil ODSC18 column (5μm, 4.6mm × 150mm), the detection wavelength was 234nm and the column temperature was 40 ℃. Results: The linear range of 125-5000ng · ml-1, the lowest detection limit of 20ng · ml-1. The method recoveries of low, medium and high concentrations were 105.76%, 93.60% and 91.89% respectively. Days, day RSD were less than 5%. Conclusion: The method is simple, accurate and sensitive and can be used for the bioavailability and pharmacokinetics of metformin hydrochloride.