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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.
J Mass Spectrom. 2005 Nov; 40(11):1462-71.JM

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 x 2.1 mm, i.d., 3 microm). 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.

Authors+Show Affiliations

Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, 74 Zhongshan Road II, Guangzhou 510080, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16255063

Citation

Zhong, Guo-Ping, et al. "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 : JMS, vol. 40, no. 11, 2005, pp. 1462-71.
Zhong GP, Bi HC, Zhou S, et al. 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. J Mass Spectrom. 2005;40(11):1462-71.
Zhong, G. P., Bi, H. C., Zhou, S., Chen, X., & 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 : JMS, 40(11), 1462-71.
Zhong GP, et al. 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. J Mass Spectrom. 2005;40(11):1462-71. PubMed PMID: 16255063.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Zhong,Guo-Ping, AU - Bi,Hui-Chang, AU - Zhou,Shufeng, AU - Chen,Xiao, AU - Huang,Min, PY - 2005/10/29/pubmed PY - 2006/3/18/medline PY - 2005/10/29/entrez SP - 1462 EP - 71 JF - Journal of mass spectrometry : JMS JO - J Mass Spectrom VL - 40 IS - 11 N2 - 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 x 2.1 mm, i.d., 3 microm). 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. SN - 1076-5174 UR - https://www.unboundmedicine.com/medline/citation/16255063/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_ L2 - https://doi.org/10.1002/jms.907 DB - PRIME DP - Unbound Medicine ER -