A systematic stability evaluation of analytical RP-HPLC columns.
HPLC column stability is one of the critical factors that determine the success of a method while supporting the life cycle of a pharmaceutical product. A systematic approach for the evaluation of HPLC column stability has been developed with emphasis on the practicality of the application to pharmaceutical analysis. This paper describes the specifics of the experimental design, evaluation criteria used and result obtained for some of the most widely used analytical columns from highly reputable column manufacturers. A stability profile over the most commonly used pH range was established that may serve as a reference for column scouting during method development.
Ye
Connie
C
Analytical Sciences, Chemical Development, GlaxoSmithKline, King of Prussia, PA 19406, USA. Connie.2.Ye@gsk.com
Terfloth
Gerald
G
Li
Yan
Y
Kord
Alireza
A
D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation* / Q000592:standards; D004867:Equipment Design; D006863:Hydrogen-Ion Concentration; D004364:Pharmaceutical Preparations / Q000032:analysis*
D004364:Pharmaceutical Preparations