Validation of an analytical method by high-performance liquid chromatography and microbiological assay, biological safety and in silico toxicity for danofloxacin



Título del documento: Validation of an analytical method by high-performance liquid chromatography and microbiological assay, biological safety and in silico toxicity for danofloxacin
Revue: Brazilian Journal of Pharmaceutical Sciences
Base de datos: PERIÓDICA
Número de sistema: 000451354
ISSN: 1984-8250
Autores: 1
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Instituciones: 1Universidade Federal do Pampa, Laboratorio de Pesquisa em Desenvolvimento e Controle de Qualidade, Uruguaiana, Rio Grande do Sul. Brasil
2Universidade Federal do Pampa, Laboratorio de Microbiologia, Uruguaiana, Rio Grande do Sul. Brasil
3Universidade Federal do Pampa, Nucleo de Pesquisa em Bioquimica, Toxicologia e Imunologia, Uruguaiana, Rio Grande do Sul. Brasil
Año:
Volumen: 56
País: Brasil
Idioma: Inglés
Tipo de documento: Artículo
Enfoque: Experimental, aplicado
Resumen en inglés Danofloxacin is a veterinary fluoroquinolone used to treat respiratory and gastrointestinal diseases of birds, pigs and cattle. The literature reviewed shows some analytical methods to quantify this fluoroquinolone, but microbiological and biological safety studies are limited. The analytical methods were validated by the Official Codes. The LC-DAD method was developed and validated using an RP-18 column, mobile phase containing a mixture of 0.3% triethylamine (pH 3.0) and acetonitrile (85:15, v/v). The microbiological assay was performed by agar diffusion method (3 x 3) and Staphylococcus epidermidis as a microorganism test. Forced degradation studies were performed in both methods. The minimum inhibitory concentration (MIC) was performed by test microdilution and toxicity studies were evaluated using in silico study, cell proliferation, cell viability test, micronuclei and comet assay. LC and a microbiological assay proved linear, accurate, precise, and robust to quantify danofloxacin, but only the LC method showed selectivity to quantify the drug in the presence of its degradation products. These results demonstrate that the LC method is suitable for stability studies of danofloxacin, but a microbiological assay cannot be used to quantify the drug due to the biological activity of the photoproducts. Ex-vivo cytotoxicity and theoretical and experimental genotoxicity were also observed
Disciplinas: Química
Palabras clave: Química farmacéutica,
Química analítica,
Danofloxacina,
Ensayos microbiológicos,
Bioseguridad,
Toxicología,
Fluoroquinolonas,
Fotodegradación
Keyword: Medicinal chemistry,
Analytical chemistry,
Danofloxacin,
Microbiological assays,
Biosafety,
Toxicology,
Fluoroquinolones,
Photodegradation
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