Title of article :
Strategy for ruggedness tests in chromatographic method validation Original Research Article
Author/Authors :
A. Nijhuis، نويسنده , , H.C.M. van der Knaap، نويسنده , , S. de Jong، نويسنده , , B.G.M. Vandeginste، نويسنده ,
Issue Information :
روزنامه با شماره پیاپی سال 1999
Abstract :
The search for sources from which small changes have an influence on the response of an analytical system, the ruggedness test, has become an essential part of a validation study. However, the `definitionʹ of ruggedness and how to perform a ruggedness test are still ambiguous. In this paper a strategy is proposed to perform a ruggedness test for chromatographic methods. Because the strategy is based on saturated designs, ANOVA cannot be applied to estimate the error variance. Therefore a graphical technique, the half-normal plot, is used to detect influential effects. In order to identify influential effects, the algorithms of Lenth and Dong are applied to four different examples. If a main effect is found to be significant, the confounded two-factor interactions are resolved by a follow-up design. The strategy of this sequential design is implemented in a SAS® software application called TRIC, testing ruggedness in chromatography.
Keywords :
Ruggedness , Chromatography , Half-normal plot , Fractional factorial design , Plackett–Burman design
Journal title :
Analytica Chimica Acta
Journal title :
Analytica Chimica Acta