Enrofloxacino: desenvolvimento de métodos analíticos e perfil de dissolução baseado em dados in vivo

Abstract

The enrofloxacin is an antibacterial drug used exclusively in veterinary clinic. To date, there are no official papers for the quality control of this drug in its pharmaceutical forms. In the present work, analytical methods for quantitative determination of enrofloxacin contained in palatable tablets were developed and validated by: (a) UV spectrophotometry using pH 7.4 phosphate buffer: ethanol (95: 5, v / v) as solvent, 273 nm with a concentration range from 0.5 to 8.0 ug. ml-1. (B) HPLC detection at 278 nm with a diode array detector, a mobile phase consisting of 0.04 M phosphate buffer (pH 2.7 and 0.3% of triethylamine) and 75% acetonitrile (75:25, v / v ), concentration range from 20.0 to 80.0 ug ml-1 and average retention time of 6 minutes; And (c) dissolution method based on in vivo data using up 400ml of medium containing HCl and pepsin soy lecithin, paddle apparatus, 75 rpm speed and quantification of the drug by UV visible spectrophotometry. Validation of all developed methods was performed by analysis of parameters: specificity, linearity, precision, accuracy and robustness, as provided for medicines for veterinary use by VICH and all results confirmed that the developed methods are useful for the control enrofloxacin routine quality in palatable tablets.