Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios
DOI:
https://doi.org/10.34119/bjhrv2n5-039Keywords:
Dexchlorpheniramine, Bethametasone, Bioequivalence, UPLC-MS/MSAbstract
This study was carried out in order to compare the relative bioavailability of two different formulations containing 2.00 mg of dexchlorpheniramine maleate + 0.25 mg of bethametasona, test formulation (Dexmine®) and reference formulation (Celestamine®) in healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 2 x 2. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical method employed the ultra-performance liquid chromatography triple quadrupole tandem mass spectrometry, using as the internal standard brompheniramine. Non-compartmental model was applied to determine different pharmacokinetic parameters and these were calculated from the plasma concentrations obtained from the volunteer samples. Bioequivalence between test and reference formulation were demonstrated as the calculated 90 % confidence interval for the corresponding ratios of log transformed pharmacokinetic parameters (Cmax, AUC0-t and AUC0-?) fell within the 80–125 % range, the predetermined criterion for therapeutic equivalence. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable.
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