Cetirizina: validação de metodologia, avaliação biofarmacotécnica e estudo preliminar da estabilidade

Abstract

Cetirizine is an antihistamine of second-generation used to relieve physical symptoms of allergic rhinitis. The benefits of possessing initial fast action, delayed effect and less cholinergic and sedative activity, comparing with other compounds of the same class are highlighted. The drug is commercially available as tablets, oral solution and compounded capsules. There are no official monographs, up to this moment, to control the quality of this drug in its pharmaceutical forms. In the present work, methods for the quantification and dissolution evaluation of the drug in tablets and capsules were developed and validated. Comparative studies among some commercially formulations and a preliminary stability study of tablets were also conducted. UV spectrophotometry, liquid chromatography, and capillary electrophoresis methods were developed and validated for quantitative determination, and showed linearity, precision and accuracy. The selected conditions for the dissolution test were 900 mL of 0.1 N HCl as medium, using paddles for tablets and basket for capsules, with rotation speed of 50 rpm. The comparative study presented that some products showed quality deviations. Moreover, we observed that important characteristics for solid oral pharmaceutical formulations were modified after three months storage at 40ºC ± 2ºC and 75% ± 5% relative humidity.