Abstract
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.
Highlights
INTRODUCTIONDanofloxacin (DAN) (1-cyclopropyl-6-fluoro-7[(1S,4S)-5-methyl-2,5-diazabicyclo[2.2.1]heptan-2-yl]4-oxoquinoline-3-carboxylic acid) is a fluoroquinolone synthetic analogue of ciprofloxacin and was introduced in the world market in 1991 for the treatment of diseases related to the respiratory and gastrointestinal tracts of birds, pigs and cattle (Mckellar, Gibson, McCormac, 1998; Kaur et al, 2012)
The mobile phase consisting of 0.3% triethylamine pH 3.0 and acetonitrile (85:15, v/v) showed the best system suitability values, with suitable resolution between the drug and the degradation products and results in terms of peak parameters according to the range recommended (USP 38, 2015)
The results showed that the drug potency was not decreased using the degraded samples under photolytic conditions, suggesting that the photodegradation products have biological activity, which limits the drug quantification in stability studies using the microbiological assay
Summary
Danofloxacin (DAN) (1-cyclopropyl-6-fluoro-7[(1S,4S)-5-methyl-2,5-diazabicyclo[2.2.1]heptan-2-yl]4-oxoquinoline-3-carboxylic acid) is a fluoroquinolone synthetic analogue of ciprofloxacin and was introduced in the world market in 1991 for the treatment of diseases related to the respiratory and gastrointestinal tracts of birds, pigs and cattle (Mckellar, Gibson, McCormac, 1998; Kaur et al, 2012). (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), describe and recommend drugs for stability studies with a view to developing methods for the quantification, identification and structure elucidation of drugs and their respective degradation products. This is one of the minimum requirements for the registration of drugs and drug products. The potential toxicity of degradation products was evaluated by different software in order to verify if the drug could damage biological cells
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