【摘要】 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。更多还原

【Abstract】 Objective: To establish a HPLC procedure to determine metformin hydrochloride in human plasma. Method: The plasma was deproteinized by acidified acetonitrile and purified with dichloromethane. A Hypersil ODS C18 column (5 μm,4. 6 mm×150 mm) with a mobile phase consisting of methanol-5 mmol·l-1 phosphate buffer(pH 6.6) (51: 49, SDS 0. 1 g per 100 ml) was used, the detecting wavelength was at 234 nm, column temperature was 40 ℃. Result: The linear range was within 125-5 000 ng·ml-1 and the limit for detection was 20 ng·ml-1 (S/N =3). The method recovery rates for plasma concentration of 250, 1 000, 3 000 ng·ml-1 were 105. 76% ,93. 60% , and 91.89%, respectively. Intra-day and inter-day precisions of the method were <5%. Twelve Chinese healthy male volunteers were given orally a single dose of 1 g metformin hydrochloride, the range of the plasma concentration were within 130.76-3 849.49 ng·ml-1 at 0. 33-16 h.Conclusion: The method is accurate, sensitive, and rapid, and can be used in the studies of bioavailability and pharmacokinetics of metformin hydrochloride.更多还原