Desenvolvimento e validação de um método indicativo de estabilidade por cromatografia líquida de alta eficiência para determinação simultânea de diferentes antiparasitários em suas formulações farmacêuticas veterinárias

Abstract

This study describes an analytical method for the simultaneous determination of febantel, toltrazuril, thiabendazole and fluazuron in bulk and their veterinary pharmaceutical formulations using high-performance liquid chromatography (HPLC). In order to investigate stability, pharmaceutical products were submitted to degradation processes under different conditions, such as recommended by the International Conference on Harmonization (ICH). The chromatographic conditions were optimized using a C18 column Zorbax Eclipse Plus (100 x 3,0 mm, 3.5 µm of particle size) under room temperature with gradient programing of mobile phase A (acetic acid watery solution 0.1% W/W) and mobile phase B (acetonitrile) and flow rate of 1.0 mL.min-1 elution time of 10 min, and UV detection wavelength of 250nm. Under these conditions, retention time of study pharmaceuticals was: thiabendazole in 2.8 min; febantel in 5.7 min; toltrazuril in 6.1 min; and fluazuron in 8.1 min. Standard curves were linear at the concentration range of 175 - 325 µg.mL-1 (correlation coefficient > 0.99). Validation parameters, such as selectivity, linearity, detection limit (0.004 – 0.118 µg.mL-1), quantification limit (0.015 – 0.393 µg.mL-1), precision (relative standard deviation < 3.97%), accuracy (98.51 – 99.94%), and robustness showed results within acceptable standards. Therefore, the method developed can be applied successfully to routine quality control in the