RUGGEDNESS TESTING OF A SIZE-EXCLUSION CHROMATOGRAPHIC ASSAY FOR LOW-MOLECULAR-MASS POLYMERS

A ruggedness test of a size-exclusion chromatographic assay for a low- molecular-mass polymer mixture was performed by applying a fractional factorial design. Eight factors selected from the method procedure wer e examined at three levels by reflecting the design. The effects of th e factors were calculated and interpreted, statistically as well as gr aphically. The statistical interpretation method based on the use of t wo-factor interaction effects to estimate experimental error was found to be effective to indicate significant effects in a ruggedness test. The factors column manufacturer and detector type turned out to be th e least robust. Variations in the other factors, within the levels exa mined, do not lead to chromatographically relevant changes.