Validation of analytical method by UV spectrophotometric quantification of gemfibrozil incorporated in the microemulsions

• María Herrera P. ^[1] ; José Cantos C. ^[1] ; Kevin Muñoz S. ^[1] ; Jovan Durán A. ^[3] ; Julio Vinueza G. ^[2] ; Fernanda Kolenyak dos Santos ^[1]
  1. [1] Universidad de Guayaquil

     Universidad de Guayaquil

     Guayaquil, Ecuador

     
  2. [2] Pontificia Universidad Católica del Ecuador

     Pontificia Universidad Católica del Ecuador

     Quito, Ecuador

     
  3. [3] Universidad Estadual Paulista

  Mostrar afiliaciones +
• Localización: infoANALÍTICA, ISSN 2477-8788, ISSN-e 2602-8344, Vol. 9, Nº. 1, 2021, págs. 137-150
• Idioma: inglés
• Enlaces
  • Texto completo (pdf)
• Resumen

  • The present study aims to validate an analytical method by UV spectrophoto-metric for the quantification of gemfibrozil incorporated into microemulsions.Experimental development by constructing a ternary phase diagram for the iden-tification of microemulsions. The characterization of the microemulsions was carried out by the polarized light microscopy technique. The analytical methodwas validated according to the parameters described by the United State Phar-macopeia (USP) 39 NF34 and International Conference on Harmonization(ICH) (2005), which evaluated linearity, robustness, intra and inter day accuracy,specificity accuracy, limits of detection and quantification. The developed met-hod demons trated linearity with a coefficient of determination (R2) of 0.9898,in addition to precision, accuracy and robustness for each of the tests with va-lues that presented a coefficient of variation of less than 5 %. The results obtai-ned were favorable, since they comply with the parameters stipulated by USP39-NF34 (2016) and ICH (2005), indicating that the method is effective for theintended purpose.