DESENVOLVIMENTO E VALIDAÇÃO DE MÉTODO ANALÍTICO PARA DETERMINAR O DOSEAMENTO DE CINARIZINA EM CÁPSULAS MAGISTRAIS

Abstract

Background: Cinnarizine is a brain vasodilator used in labyrinth diseases, a disorder characterized by dizziness, gait deviations, or falling. The quality control of compounded capsules containing cinnarizine is limited. Because of the difficulty accessing official pharmacopeia monographs of this drug, there is a need to describe an analytical method that is reliable and safe to perform the quantitative determination of cinnarizine in capsules. Aim: This work aims to develop and validate an analytical method to determine cinnarizine assay in capsules by spectrophotometry in the UV region that is easy to perform, low cost, and offers reliability in the dosage results. Methods: The RDC nº. 166, of 24 July 2017, of the National Health Surveillance Agency, was used as the guide for validating analytical methods. Results and Discussion: 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 accuracy results (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 cinnarizine in capsules of pharmacies of the retail trade of Barra do Garças - MT was determined. The results were found to comply with Farmacopéia Brasileira 6th Edition requirements. Conclusions: The validated analytical method proved to be linear, specific, accurate, and robust and allows the determination of the dosage of cinnarizine in compounded capsules in a simple way, with low cost, and provides reliable results.