Simultaneous quantification of budesonide and its two metabolites, 6beta-hydroxybudesonide and 16alpha-hydroxyprednisolone,in human plasma by liquid chromatography negative electrospray ionization tandem mass spectrometry |
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Authors: | Wang Yaning Tang Yufei Moellmann H Hochhaus Günther |
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Institution: | Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, FL 32610, USA. |
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Abstract: | A sensitive, rapid and selective liquid chromatography negative electrospray ionization tandem mass spectrometry LC-(-)ESI-MS-MS] method has been developed and validated for the simultaneous quantification of budesonide (BUD) and its major metabolites, 6beta-hydroxybudesonide (OH-BUD) and 16alpha-hydroxyprednisolone (OH-PRED) in human plasma. The method was validated over a linear range from 0.1 to 10 ng/mL for all three analytes using a solid-phase extraction procedure with 9-fluoro-hydrocortisone as the internal standard. The between-day and within-day coefficients of variation for all compounds were < or =20% at the concentrations of lower limit of quantification and < or =15% at other quality control concentrations. The utility of this assay was demonstrated by monitoring BUD, OH-BUD and OH-PRED plasma concentrations in one healthy subject for 24 h following a 3 mg oral dose of budesonide, administered as a pH modified release capsule (Budenofalk) to healthy volunteers. |
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