Author(s): Ye C, Terfloth G, Li Y, Kord A
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Abstract 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.
This article was published in J Pharm Biomed Anal
and referenced in Journal of Analytical & Bioanalytical Techniques