Desenvolvimento e validação de método analítico para determinar o doseamento de cinarizina em cápsulas magistrais

Abstract

Cinarizine is a brain vasodilator used in labyrinth diseases, which is a disorder characterized by dizziness, gait deviations or feeling of falling. By the fact the quality control of compounded capsules containing cinarizine is limited, and because of the difficulty in accessing official pharmacopoeia monographs of this drug, there is a need to describe an analytical method that is reliable and safe to perform the quantitative determination of cinarizine in capsules. This work aims to develop and validate an analytical method to determine the assay of cinarizine in capsules by spectrophotometry in the UV region that is easy to perform, low cost and that offers reliability in the dosage results. The proposed method was linear in the range of 5.833 to 10.833 μg mL-1, and presented similar results of linear and Person correlation coefficient (0.999), selectivity/specificity (0.14 %), detection limits (130, 20 ng/mL) and quantification (260, 40 ng/mL) at 251 nm. The results of accuracy (DPR Rep. accuracy: 2.89 %; DPR Inter. accuracy: 1.07 %) and precision (CQB= 99.96 %, CQM= 100.02 % and CQA= 100.06 %) complied with the validation parameters. The robustness has been proven and the analytical method does not vary significantly from small deliberations. After validation the assay of cinarizine in capsules of pharmacies of the retail trade of Barra do Garças - MT was determined. The results found complied the requirements of Farmacopéia Brasileira 6th Edition. The validated analytical method proved to br linear, specific, accurate and robust and allows the determination of the dosage of cinarizine in compounded capsules in a simple way, with low cost and provides reliable results.