Development and Validation of an UV-Derivative Spectrophotometric Method for Determination of Glimepiride in Tablets

نویسندگان

  • Rudy Bonfilio
  • Magali B. de Araújo
  • Hérida R. N. Salgado
چکیده

A glimepirida é um fármaco antidiabético oral usado no tratamento da diabetes tipo 2. Este trabalho propôs o desenvolvimento e validação de um método por espectrofotometria derivada na região do ultravioleta para determinação de glimepirida em comprimidos. A quantificação de glimepirida em solução de NaOH 5×10 mol L foi realizada usando um intervalo de 8 nm entre 220 a 300 nm. Os valores de amplitude do espectro de segunda derivada foram obtidos através de unidades de altura de pico entre a linha de base e os sinais em 279,0, 257,5 e 256,3 nm, para quantificação dos produtos Amaryl 1 mg, Amaryl 2 mg e Amaryl 4 mg, respectivamente. O método foi completamente validado de acordo com o International Conference on Harmonization (ICH) e demonstrou exatidão, precisão, seletividade, robustez e linearidade. O método validado mostrou-se adequado para aplicações em laboratórios de controle de qualidade, pois não utiliza reagentes poluentes, é de simples execução e possui baixo custo.

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تاریخ انتشار 2011