Comentários desativados em v11n4doi10.5935/sc.2019.014

v11n4doi10.5935/sc.2019.014

http://dx.doi.org/10.5935/sc.2019.014

Efficient UPLC and spectrophotometric MC methods for simultaneous determination of cefixime and sodium benzoate in their dosage form and in its degradation product of cefixime-E Isomer. Application of lean six sigma and in-vitro dissolution studies

Mohamed M. A.

Palavras chaves: não enviado pelo autor.

Resumo: O objetivo principal deste estudo é desenvolver e validar um novo RP-UPLC e métodos espectrofotométricos de centralização média para a estimativa simultânea de cefixima e benzoato de sódio em sua forma farmacêutica e em seu produto de degradação do isômero cefixima-E e aplicação de ferramentas de qualidade e Lean Metodologias Seis Sigma para interpretar a integridade dos dados de atributos de qualidade que darão força, confiança e precisão para controlar e enfatizar que o Índice de Capacidade do Processo (Cpk) é> 1,33. A condição cromatográfica isocrática foi avaliada à temperatura ambiente usando coluna Waters CORTECS® C18 (50 mm × 4,6 mm, tamanho de partícula 2,7 μm), com uma fase móvel composta de acetonitrila: tampão fosfato 0,05 M (35:65 v / v) na taxa de fluxo de 0,3 mL / minuto e detecção de UV a 230 nm com volume de injeção de 0,5 µL e tempo total de execução de 7 min. O método de UV é a centralização média dos espectros de razão (MC), que se baseia na centralização média dos primeiros dados espectrais de razão de ambas as drogas em sua mistura binária a 225 nm para SDB, enquanto CFX foi detectado em espectros de ordem zero de 290 nm , já que nenhuma sobreposição da droga combinada foi encontrada. O método foi aplicado com sucesso a estudos comparativos de dissolução in vitro para cefixima (CFX) no produto Genérico; Rivaxime 200 mg Cap e Rivaxime 400 mg Cap portanto, havia sido considerado equivalente ao produto inovador; Suprax 200 mg Cap e Suprax 400 mg Cap usando meio de dissolução FDA.

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