Development and validation of a method for characterization and quantification of marbofloxacin in pharmaceutical formulation for animal use

Karla Regina Warszawski de Oliveira; Patrícia Espinosa dos Santos; Marcos Serrou do Amaral; Teófilo Fernando Mazon Cardoso; Nájla Mohamad Kassab

doi:10.22456/dar.v10i1.156157

Authors

Karla Regina Warszawski de Oliveira Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Food, and Nutrition - Federal University of Mato Grosso do Sul https://orcid.org/0000-0002-3440-6215
Patrícia Espinosa dos Santos Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Food, and Nutrition - Federal University of Mato Grosso do Sul https://orcid.org/0000-0001-7142-0297
Marcos Serrou do Amaral Institute of Physics - Federal University of Mato Grosso do Sul https://orcid.org/0000-0001-8101-6933
Teófilo Fernando Mazon Cardoso Laboratory of Pharmaceutical Technology
Nájla Mohamad Kassab Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Food, and Nutrition - Federal University of Mato Grosso do Sul https://orcid.org/0000-0002-9324-4252

DOI:

https://doi.org/10.22456/dar.v10i1.156157

Keywords:

Fluoroquinolone, Marbofloxacin, Spectrophotometry, Method Validation, Validation

Abstract

Marbofloxacin (MFN) is a fluoroquinolone drug used in veterinary medicine to treat dogs and cats with skin and appendage infections, urinary tract infections, gastrointestinal infections, and respiratory infections. The objective of this study was to develop and validate an analytical method for determining MFN in palatable tablets for animal use. The MFN raw material was characterized using thin-layer chromatography, infrared (IR) absorption spectroscopy, and melting range spectroscopy to ensure its quality for use in validating the spectrophotometric analytical method. Method validation was performed based on the parameters of specificity, linearity, precision, accuracy, limits of detection and quantification, and robustness. In the calibration curve from 5 to 15 µg mL^-1, the correlation value was 0.9990, in repeatability and intermediate precision the relative standard deviation was less than 1%, and the mean recoveries were 101.53 ± 0.4, the limits of detection and quantification were 0.033 and 0.625 μg mL^-1, respectively. The method developed and validated for the quality control of MFN was sensitive, linear, precise, accurate and robust for its determination in pharmaceutical formulations for veterinary use.

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