Validação de técnica analítica em LC-MS/MS para quantificação da ivermectina em plasma canino

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2022-11-17

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Universidade Federal de Goiás

Resumo

Ivermectin is an antiparasitary drug with endectocide activity, which is derived from avermectin, a macrocyclic lactone isolated from actinomycete Streptomyces avermectinus. This study aims to validate a new ivermectin’s analytical methodology, in dog plasma, with pharmacokinetic and bioavailability studies as objectives, regarding the still necessary clinical studies in dogs for veterinary products approval. Moreover, the optimized and developed method had as objective to have analytical benefits over the existent methods. The chosen analytical technique was High Performance Liquid Chromatography coupled to Mass Spectrometry (HPLC-MS/MS) with a Zorbax® C18 column from AgilentTM and, as mobile phase, 90:10 (Methanol:water) with 0,1% formic acid and 5 mM ammonium formate being added to aqueous and organic phases. The internal standard of choice was abamectin due to high similarity with ivermectin. Analytical validation was performed through a calibration curve with 7. Precision and accuracy intra-day and inter-day results were obtained through triplicate concentrations of quality control samples. Intra-day precision had 4,0 – 14,9% CV values and inter-day 6,4 – 11,6%. Intra-day accuracy had values between 95,0 and 114,61% and inter-day 98,1 and 109,0%. Stability studies had values between 88,8 and 98,2%. All results agree with parameters stablished by RDC nº27/2012. The analytical technique was used to determine ivermectin’s p.o. kinetic profile of a 2-year-old female mongrel dog weighting 14 kg, and proved adequate to quantificate typical concentration variations of pharmacokinetic data: Cmáx = 17,85 ng/mL; Tmáx = 1,00 h; AUC0-inf_obs = 2113,21 ng/mL*h; Vd = 41,24 L/Kg. The optimized and developed method had reduced use of organic solvents in its extraction method, faster analytical run, lower sample volume and can be used in pharmacokinetical studies.

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TOLEDO, N. R. Validação de técnica analítica em LC-MS/MS para quantificação da ivermectina em plasma canino. 2023. 62 f. Dissertação (Mestrado em Ciências Farmacêuticas) - Faculdade de Farmácia, Universidade Federal de Goiás, Goiânia, 2022.