CaracterizaÃÃo e desenvolvimento de mÃtodos analÃticos do ornidazol

AUTOR(ES)

Elda Azevedo Guerra

DATA DE PUBLICAÇÃO

2007

RESUMO

The nitroimidazoles drugs acts to inhibit the synthesis of microbial DNA, this class presents the metronidzole as drug of choice. The ornidazol, derivative of the 5-nitroimidazoles, presents therapeutic advantages in relation to metronidazole, by presenting a bigger half-life, causing the reduction in the dosage frequency and the duration of the treatment in the majority of the clinical infections of greater relevance. The orninidazole can be synthesized by differents synthesis routes, possibly presenting different correlated chemical substances (CCS) also known as impurities. This work aimed the thermal characterization of the drug and the development and validation of analytical methods applied on the quality control of rawmaterial and pharmaceutical form film-coated tablet. Three raw-materials of different suppliers had been analised by spectrophotometric, thermoanalytical and chromatographic techniques. Two quantitative analytical methods were developed and validated for ornidazoleâs assay, the first being an analytical method able to quantify simultaneously the ornidazole and their CCS by High Performance Liquid Chromatography (HPLC) and the second having propouse of analyses the final product by Ultraviolet-Visible Spectrophotometry (UV-VIS). One third analytical method of performance was developed and validated for the accomplishment of the pharmaceutical form dissolution test. By the thermal methods was possible to prove the ornidazole raw-material purity, investigate the ornidazoleâs kinetic of degradation and carry out a compatibility test between the drug ornidazole and consecrated excipients in the practical pharmaceutical, by the characterization of the drug, excipients, binary mixture and final pharmaceutical form. The raw-materials from the three suppliers had presented adequate quality and the developed and validated analytical methods had shown satisfactory results for all the evaluated parameters. Ahead of the obtained results, the attainment of the pharmaceutical form tablet base of ornidazol with proven quality and trustworthiness can be guaranteed, fundamental requisites for the medicine manufacture according to the Good Manufacturing Practice (GMP), praised for the regulatorie agency (ANVISA-HM)

ASSUNTO(S)

analytical methods caracterizaÃÃo tÃrmica ornidazole quality control controle de qualidade development ornidazol farmacia desenvolvimento thermal characterization validaÃÃo validation mÃtodos analÃticos

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