DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD TO QUANTIFY THE DISSOLUTION OF CINARIZIN IN CAPSULES COMPOUNDED

Abstract

Cinnarizine (CIN) is used in the treatment of cerebral circulatory, peripheral circulatory and balance disorders. An analytical method was developed and validated to determine the dissolution of cinnarizine (CIN) in capsules compounded by ultraviolet detection spectrophotometry. The resolutions of the Agência Nacional de Vigilância Sanitária nº. 899 of May 29, 2003 and nº. 166 of July 24, 2017 were used as the guide for validation of analytical methods. CIN showed high solubility in 0.1 mol.L-1 hydrochloric acid at 37 ° C (9.43 mg.mL-1), selectivity / specificity in the presence of other components (0.35 %), maximum absorption spectrum in 251 nm; linearity (r = 0.9999); precision (RSD repet.: 0.09%, RSD inter.: 1.10%); accuracy (LQC = 99.9%, MQC = 99.5%, HQC = 100.7%); limits of detection and quantification of 0.042 and 0.42 μg.mL-1, respectively. In the parameter robustness it has been proven that the proposed method does not suffer significant variations. The validated analytical method is easy to perform and has reliable selectivity / specificity, linearity, precision, accuracy, limits of detection, limits of quantification and robustness. Therefore, the ultraviolet detection spectrophotometry method is applicable to determine CIN in capsules compounded in simple, accurate and low cost dissolution assays.