Simultaneous determination of metformin and gliclazide in human plasma by liquid chromatography-tandem mass spectrometry: Application to a bioequivalence study of two formulations in healthy volunteers

Zhong, G, Bi, H, Zhou, S, Chen, X and Huang, M 2005, 'Simultaneous determination of metformin and gliclazide in human plasma by liquid chromatography-tandem mass spectrometry: Application to a bioequivalence study of two formulations in healthy volunteers', Journal of Mass Spectrometry, vol. 40, no. 11, pp. 1462-1471.


Document type: Journal Article
Collection: Journal Articles

Title Simultaneous determination of metformin and gliclazide in human plasma by liquid chromatography-tandem mass spectrometry: Application to a bioequivalence study of two formulations in healthy volunteers
Author(s) Zhong, G
Bi, H
Zhou, S
Chen, X
Huang, M
Year 2005
Journal name Journal of Mass Spectrometry
Volume number 40
Issue number 11
Start page 1462
End page 1471
Total pages 10
Publisher John Wiley & Sons Ltd.
Abstract A rapid and sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method was developed and validated to simultaneously determine gliclazide and metformin in human plasma using huperzine A as the internal standard (IS). After acetonitrile-induced protein precipitation of the plasma samples, gliclazide, metformin and the IS were subjected to LC/MS/MS analysis using electro-spray ionization (ESI). Chromatographic separation was performed on a Hypersil BDS C18 column (50 mm × 2.1 mm, i.d., 3 μm). The method had a chromatographic running time of 2.0 min and linear calibration curves over the concentration ranges of 10-10 000 ng ml-1 for gliclazide and 7.8-4678.9 ng ml-1 for metformin. The recoveries of the method were found to be 71-104%. The lower limits of quantification (LOQ) of the method were 10.0 and 7.8 ng ml-1 for gliclazide and metformin, respectively. The intra- and interday precision was less than 15% for all quality control samples at concentrations of 100, 500, and 2000 ng ml -1. The validated LC/MS/MS method has been used to study bioequivalence in healthy volunteers. These results indicate that the method was efficient with a very short running time (2.0 min) for metformin and gliclazide compared to the methods reported in the literature. The presented method had acceptable accuracy, precision and sensitivity and was used in clinical bioequivalence study.
Subject Physical Chemistry not elsewhere classified
DOI - identifier 10.1002/jms.907
ISSN 1076-5174
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