Development and Validation of a Multivariate Calibration Model for Determination of Dipyrone in Oral Solutions by Near Infrared Spectroscopy

نویسندگان

  • Marcus H. Ferreira
  • Jorge F. F. Gomes
  • Marcelo M. Sena
چکیده

Este trabalho propôs um novo método para a determinação de dipirona (DIP) em soluções orais farmacêuticas, usando medidas de transflectância no infravermelho próximo (NIR) e calibração multivariada. A faixa de estudo foi de 300,0 a 569,2 mg mL de DIP. O melhor modelo PLS foi obtido com 2 variáveis latentes e apresentou erros médios quadráticos de calibração e de previsão (RMSEC e RMSEP) iguais a 1,1 e 1,0 mg mL, respectivamente. O método foi validado de acordo com as resoluções da ANVISA e do ICH e foi considerado seletivo, linear, preciso, exato e robusto. Em comparação com as principais alternativas, titulação iodimétrica e CLAE, este método é mais simples, não-destrutivo, não gasta reagentes ou solventes nem gera resíduos. Além disso, a maior vantagem está na rapidez da análise, pois são gastos cerca de 50 s.

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تاریخ انتشار 2009