Determination and validation of secnidazole in tablets by UV spectrophotometric = Determinação e validação do secnidazol em comprimidos por espectrofotometria na região do ultravioleta

Márcia Regina Marcílio, Alexia Lorenzi Raiser, Ligia Paula Fumagalli, Rudy Bonfilio, Carla Regina Andrighetti, Elton Brito Ribeiro, Denia Mendes de Sousa Valladão

Abstract


Secnidazole, a 5-nitroimidazole, is a drug used in the treatment against protozoa, and several bacterial infections.  This study purpose was to develop and validate a UV spectrophotometric method  to determine secnidazole in pharmaceutical tablet dosage forms once there is no method reported in the pharmacopoeia yet. The quantification was performed using methanol as solvent at 325 nm (maximum wavelength) and three kinds of products marketed in Brazil (reference, generic and similar tablets) containing 1g of secnidazole.  The method obeyed Beer’s law in the concentration range of 4 - 20 mgmL-1 respectively. The method was validated according to the International Conference on Harmonization (ICH) and Brazil National Health Surveillance Agency (ANVISA) guidelines, showing accuracy, precision, selectivity, robustness and linearity. Tests such as weight  range, friability, disintegration, hardness and dissolution were carried out to check  tablets’ quality and all the trials showed to be in accordance with the  general test guidelines of the Brazilian Pharmacopoeia. The dissolution test was carried out and the developed method  was applied. The method developed is suitable for the estimation of secnidazole  in tablets without any interference from the excipients and can be used for routine in quality control. Still, it's a simple, fast and low cost method.


Keywords


Quality control; Quantify; Dissolution test, Secnidazole

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Bioscience Journal
ISSN 1981-3163 - Online Journal

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