Abstract
The aim of this paper was to develop, validate, and utilize a sensitive liquid chromatography-tandem mass spectrometry bioanalytical method for bioequivalence/clinical trial studies conducted in human plasma. To accomplish the target, a stable labeled internal standard, that is, dexamethasone D4 was used as an internal standard to track and compensate the parent compound during processing, and extraction from plasma. The method involves a rapid liquid-liquid phase extraction from plasma, followed by reverse phase chromatography, and mass spectrometry detection, with a total run time of 3.5 min. The method was developed and validated from 2 to 600 ng/ml for dexamethasone. The mean recovery for dexamethasone was found to be 81.0%. The validated method enabled the analysis of dexamethasone in samples from clinical pharmacokinetic studies. The peak concentration of dexamethasone ranged between 253 to 281 ng/ml and 319 to 343 ng/ml, respectively, in fasted and fed conditions. The terminal half-life values for dexamethasone ranged between 3.5 to 8.2 h and 3.0 to 7.5 h, respectively.
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Schedule a callMore From: European journal of mass spectrometry (Chichester, England)
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