Validation of a HPLC Method for the Determination of Metformin in Human Plasma and its Application to a Bioequivalence Study

被引:0
作者
Kan, Xin [1 ,2 ]
Lin, Zhong [2 ]
Xiong, Jianhua [2 ]
Yang, Jinzhao [2 ]
Lin, Yuxian [2 ]
Li, Hao [2 ]
Chen, Dingwen [2 ]
Wang, Shujun [2 ]
机构
[1] Yueqing Third Peoples Hosp, Yueqing 325604, Peoples R China
[2] Wenzhou Peoples Hosp, Wenzhou 325000, Peoples R China
来源
LATIN AMERICAN JOURNAL OF PHARMACY | 2014年 / 33卷 / 05期
关键词
Bioequivalence; HPLC; Metformin; Plasma; TANDEM MASS-SPECTROMETRY; LIQUID-CHROMATOGRAPHY; PHARMACOKINETICS;
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In this study, a simple, rapid and sensitive high performance liquid chromatography (HPLC) method is described for determination of metformin (MET) in plasma samples from bioequivalence assays. Sample preparation was accomplished through protein precipitation with 35% perchloric acid and dichloromethane, and chromatographic separation was performed on an Agilent ZORBAX SB-C18 column (150 x 4.6 mm, 5 mu m) at 35 degrees C. Mobile phase consisted of a mixture of acetonitrile-water-10 mM SDS-0.1% trifluoroacetic acid in water (35:47:13:5) at flow rate of 1.0 mLmin. Wavelength was set at 234 nm. The method was applied to a bioequivalence study of two drug products containing MET, and allowed determination of MET at low concentrations with a higher throughput than previously described methods.
引用
收藏
页码:835 / 840
页数:6
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