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作 者:李德明[1] 范义凤[1] 徐新[1] 高捷[1] 季卫荣[1] 顾海膺[1]
出 处:《临床合理用药杂志》2009年第21期27-28,共2页Chinese Journal of Clinical Rational Drug Use
摘 要:目的建立测定人体血浆中盐酸二甲双胍的HPLC法。方法取血浆样品0.4ml,乙腈沉淀蛋白0.6ml。流动相为甲醇:乙腈:0.01mol/L磷酸盐缓冲液(pH7.0,65:20:15),流速1.0ml/min,检测波长233nm。结果在0.25~5.0μg/ml范围内,盐酸二甲双胍的峰高与浓度呈良好的线性关系(r=0.9993,n=7),最低检测限为50ng/ml,低、中、高3种浓度的日内和日间RSD分别为4.93%、2.73%、1.50%(n=5)和5.57%、3.02%、1.72%(n=5),相对回收率分别为95.53%,101.0%,100.6%。结论该法操作简便,灵敏度高,适用于盐酸二甲双胍的药动学研究及治疗药物浓度监测。Objective To established an HPLC method for the determination of the concentration of metformin hydrochloride in human plasma.Methods Plasma samples taken 0.4ml,acetonitrile precipitated protein 0.6ml.The mobile phase was methanol∶acetonitrile∶0.01mol/L phosphate buffer(pH7.0,65∶20∶15),flow rate 1.0ml/min,detection wavelength 233nm.Results Linear range of the standard curve was from 0.25 to 5.0μg/ml(r=0.9997),The detection limit was 50ng/ml,The precision of the intra-day and inter-day of three different concentration solutions were 4.93% ,2.73%, 1.50% ( n = 5) and 5.57% ,3.02%, 1.72% ( n = 5) respectively, and the extraction recovery was 95.53% , 101.0%, 100.6% respectively. Conclusion The method was simple sensitive and could be used for determining the concentration of mefformin in plasma and for studing pharmacokinetics of mefformin.
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