Desenvolvimento e validação de método analítico por eletroforese capilar de zona com detecção ultravioleta (CZE-UV), para a determinação simultânea de artesunato e mefloquina, em formulações farmacêuticas de dose fixa combinada

Abstract

Malaria is an infectious disease caused by a Plasmodium parasite, which is endemic in underdeveloped countries representing a serious public health problem in the world. Currently, the indicated treatment is the artemisin based combined therapy, in which the artemisin or its derivatives are associated with others antimalarial drugs. In Brazil, the artesunate-mefloquine combination is the first-choice therapy for the treatment of P. falciparum malaria and, therefore, it is important to dose these drugs to ensure that the medicine have appropriate quality, safety and efficacy. In this work, an analytical method was developed and validated for the simultaneous determination of artesunate and mefloquine in fixed-dose combination tablets by capillary zone electrophoresis with ultraviolet detection. Due to the low molar absorptivity of artesunate, a chromophore species had to be added to the electrolyte. Thus, the method consists of direct detection for mefloquine and indirect detection for artesunate, both at 214 nm. The optimized electrophoretic conditions were: polyamide coated fused silica capillary with 48.5 cm long and 50 μm internal diameter, hydrodynamic injection 30 mbar for 10 s, cartridge temperature maintained at 22.5 ° C, positive voltage of 30 kV, detection at 214 nm and electrolyte consisting of 30/15 mmol L-1 of Tris/3,5-dinitrobenzoic acid buffer. After the method development, a validation was performed by evaluating the parameters of linearity, selectivity, precision, accuracy, detection limits and quantification. All the results obtained were satisfactory.