Dissertação
Desenvolvimento e validação de metodologia analítica para avaliação de ebastina e cloridrato de pseudoefedrina em cápsulas
Fecha
2011-08-26Registro en:
DELGADO, Leila Schreiner. DEVELOPMENT AND VALIDATION OF ANALITICAL
METHODOLOGY TO EVALUATION OF EBASTINE AND
PSEUDOEPHEDRINE IN CAPSULES. 2011. 89 f. Dissertação (Mestrado em Farmacologia) - Universidade Federal de Santa Maria, Santa Maria, 2011.
Autor
Delgado, Leila Schreiner
Institución
Resumen
Ebastine is a second generation antihistaminic clinically used for the treatment of
allergic rhinitis and chronic urticaria. Pseudoephedrine hydrochloride is a direct- and indirectacting
sympathomimetic, commonly combined with other drugs for their decongestant effect.
In Brazil, this drugs association is available in capsules. In the literature, as well as in the
official compendium, there are no methods for simultaneous analysis of ebastine and
pseudoephedrine hydrochloride in pharmaceutical formulations. In the present work, liquid
chromatography (HPLC) and derivative spectrophotometry (UVD) methods were developed
and validated for quantification of this drugs association, in capsules. The HPLC analysis
were performed on a C18 column, using a mobile phase composed of methanol: acetonitrile:
ammonium acetate buffer pH 6.8 (85:5:15, v/v), run at a flow rate of 1,0 mL.min-1, with UV
detection at 254 nm. In the UVD method, ebastine was quantified in the first derivative
(dA/dλ), at 263.5 and 252.8 nm, respectively. All of them were validated in the following
parameters: linearity, precision and accuracy. The specificity was evaluated in the HPLC
assay by stress testing. The methods showed good linarity (r>0.99), precision (RSD<2%) and
accuracy; the results, statistically compared, did not show significant difference (p>0,05).