Validation of a sensitive LC–MS assay for quantification of glyburide and its metabolite 4-transhydroxy glyburide in plasma and urine: An OPRU Network study

Glyburide (glibenclamide, INN), a second generation sulfonylurea is widely used in the treatment of gestational diabetes mellitus (GDM). None of the previously reported analytical methods provide adequate sensitivity for the expected sub-nanogram/mL maternal and umbilical cord plasma concentrations...

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Bibliographic Details
Published in:Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2007-12, Vol.860 (1), p.34-41
Main Authors: Naraharisetti, Suresh Babu, Kirby, Brian J., Hebert, Mary F., Easterling, Thomas R., Unadkat, Jashvant D.
Format: Article
Language:English
Subjects:
Analysis
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Chromatography, High Pressure Liquid - methods
Diabetes, Gestational - blood
Diabetes, Gestational - urine
Female
Fundamental and applied biological sciences. Psychology
General pharmacology
Gestational diabetes mellitus
Glucuronidase - metabolism
Glyburide
Glyburide - analogs & derivatives
Glyburide - blood
Glyburide - metabolism
Glyburide - urine
Humans
Liquid chromatography–mass spectrometry
Mass Spectrometry - methods
Medical sciences
Metabolites
Pharmacology. Drug treatments
Plasma
Pregnancy
Reproducibility of Results
Sensitivity and Specificity
Umbilical cord plasma
Urine
β-Glucuronidase
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Summary:Glyburide (glibenclamide, INN), a second generation sulfonylurea is widely used in the treatment of gestational diabetes mellitus (GDM). None of the previously reported analytical methods provide adequate sensitivity for the expected sub-nanogram/mL maternal and umbilical cord plasma concentrations of glyburide during pregnancy. We developed and validated a sensitive and low sample volume liquid chromatographic–mass spectrometric (LC–MS) method for simultaneous determination of glyburide (GLY) and its metabolite, 4-transhydroxy glyburide (M1) in human plasma (0.5 mL) or urine (0.1 mL). The limits of quantitation (LOQ) for GLY and M1 in plasma were 0.25 and 0.40 ng/mL, respectively whereas it was 1.06 ng/mL for M1 in urine. As measured by quality control samples, precision (% coefficient of variation) of the assay was
ISSN:1570-0232
1873-376X
DOI:10.1016/j.jchromb.2007.10.010