title: [Application of robustness test for assessment of the measurement uncertainty at the end of development phase of a chromatographic method for quantification of water-soluble vitamins].
abstract: OBJECTIVE
  We propose in this work an efficient way to evaluate the measurement of uncertainty at the end of the development step of an analytical method, since this assessment provides an indication of the performance of the optimization process.
  
  
  METHODS
  The estimation of the uncertainty is done through a robustness test by applying a Placquett-Burman design, investigating six parameters influencing the simultaneous chromatographic assay of five water-soluble vitamins. The estimated effects of the variation of each parameter are translated into standard uncertainty value at each concentration level.
  
  
  RESULTS
  The values obtained of the relative uncertainty do not exceed the acceptance limit of 5%, showing that the procedure development was well done. In addition, a statistical comparison conducted to compare standard uncertainty after the development stage and those of the validation step indicates that the estimated uncertainty are equivalent.
  
  
  CONCLUSIONS
  The results obtained show clearly the performance and capacity of the chromatographic method to simultaneously assay the five vitamins and suitability for use in routine application.
authors.affiliation: Laboratoire de chimie organique appliquée, faculté des sciences et techniques, université Sidi Mohamed Ben Abdellah, BP 2202, route d'Imouzzer, Fès, Maroc. Electronic address: chouaibihssane@yahoo.fr.
authors.forename: B
authors.initials: B
authors.lastname: Ihssane
authors.affiliation: Laboratoire de chimie organique appliquée, faculté des sciences et techniques, université Sidi Mohamed Ben Abdellah, BP 2202, route d'Imouzzer, Fès, Maroc; Laboratoire national de contrôle des médicaments, direction de médicaments et de la pharmacie, ministère de la Santé Publique, Rabat, Maroc.
authors.forename: H
authors.initials: H
authors.lastname: Bouchafra
authors.affiliation: Laboratoire national de contrôle des médicaments, direction de médicaments et de la pharmacie, ministère de la Santé Publique, Rabat, Maroc.
authors.forename: M
authors.initials: M
authors.lastname: El Karbane
authors.affiliation: Institut supérieur des professions infirmières et techniques de santé, avenue Hassan II, route de Casa, Rabat, Maroc.
authors.forename: M
authors.initials: M
authors.lastname: Azougagh
authors.affiliation: Laboratoire de chimie organique appliquée, faculté des sciences et techniques, université Sidi Mohamed Ben Abdellah, BP 2202, route d'Imouzzer, Fès, Maroc.
authors.forename: T
authors.initials: T
authors.lastname: Saffaj
mesh_terms: D000465:Algorithms; D002845:Chromatography / Q000379:methods; D002851:Chromatography, High Pressure Liquid; D012015:Reference Standards; D015203:Reproducibility of Results; D035501:Uncertainty; D014815:Vitamins / Q000032:analysis*
chemical_list: D014815:Vitamins
keywords: Chromatographic assay of vitamins; Dosage chromatographique des vitamines; Incertitude de mesure; Measurement uncertainty; Plackett-Burman Design; Plan Plackett-Burman; Robustesse; Robustness test