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Using Plackett Burman partial factorial designs for method ...

Using Plackett Burman partial factorial designs for method robustness testingBy D. A. DurdenCanadian Food Inspection AgencyCalgary Laboratory3650 36 St NWCalgary , ABReproducibility of a method {Ruggedness{RobustnessRuggedness of a method { the degree of reproducibility of test results obtained by the analysis of the samesamples under a variety normaltest conditions USPR uggedness test conditionszDifferent{laboratories{analys ts{instruments{reagent lots{analysis days{elapsed assay times{assay temperatureszFactors are external to the methodzShould show a lack of influencezICH intermediate precision Robustness of a method a measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal use. USP, ICHF actors are internal to the methodShould show a lack of influenceTypical robustness parameters{HPLCzMobile phase compositionzNumber, type, and proportion of organic solventszBuffer composition and concentrationzpH of the mobile phasezDifferent column lots (same brand and model)zTemperaturezFlow ratezWavelengthzGradient; slope and lengthExperimental design{The scientists approachzUnivariate{Change a single variable at a timezTime consuming, inefficientzInteractions may not be detectedExperimental design 2{The statisticians approachzMultivariate{Change many variables at a timezMore efficientzMay allow observation of interactionszSome main effects may be obscuredMultivariate a}}}}}}}}}}}}}}}

Using Plackett Burman partial factorial designs for method robustness testing By D. A. Durden Canadian Food Inspection Agency Calgary Laboratory

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