Determination of the quaternary ammonium compound trospium in human plasma by LC–MS/MS: Application to a pharmacokinetic study

A highly sensitive, specific and evaporation free SPE extraction, LC–MS/MS method has been developed for the estimation of trospium in human plasma using trospium-d8 as an internal standard (IS). The analyte was separated using isocratic mobile phase on reverse phase column and analyzed by MS/MS in...

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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, 2010-04, Vol.878 (13), p.981-986
Main Authors: Hotha, Kishore Kumar, Bharathi, D. Vijaya, Kumar, Sanagapati Sirish, Reddy, Y. Narasimha, Chatki, Pankaj K., Ravindranath, L.K., Jayaveera, K.N.
Format: Article
Language:English
Subjects:
Ammonium compounds
Analysis
Analytical, structural and metabolic biochemistry
Battery
Benzilates
Biological and medical sciences
Cations
Chromatography, Liquid - methods
Elution
Extraction
Fundamental and applied biological sciences. Psychology
General pharmacology
Guidelines
Human
Human plasma
LC–MS/MS
Limit of Detection
Medical sciences
Nortropanes - blood
Nortropanes - pharmacokinetics
Pharmacokinetics
Pharmacology. Drug treatments
Quaternary Ammonium Compounds - blood
Quaternary Ammonium Compounds - pharmacokinetics
Quaternary compound
Run time (computers)
Tandem Mass Spectrometry - methods
Trospium
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Summary:A highly sensitive, specific and evaporation free SPE extraction, LC–MS/MS method has been developed for the estimation of trospium in human plasma using trospium-d8 as an internal standard (IS). The analyte was separated using isocratic mobile phase on reverse phase column and analyzed by MS/MS in the multiple reaction monitoring mode using the respective [M +] cations, m/ z 392–164 for trospium and m/ z 400–172 for the IS. The total run time was 3.50 min and the elution of trospium and trospium-d8 (IS) occurred at 2.8 min. The developed method was validated in human plasma with a lower limit of quantification of 0.05 ng/mL. A linear response function was established for the range of concentrations 0.05–10 ng/mL ( r > 0.998) for trospium in human plasma. The intra- and inter-day precision values for trospium met the acceptance as per FDA guidelines. Trospium was stable in the battery of stability studies viz., bench-top, auto-sampler, dry extracts and freeze/thaw cycles. The developed assay method was applied to an oral pharmacokinetic study in humans.
ISSN:1570-0232
1873-376X
DOI:10.1016/j.jchromb.2010.02.028