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POSTER: Inter-instrumental method transfer of capillary electrophoretic methods: The use of precision studies and robustness test information

Authors: B. De Cock, N. Delaunay, J. Stiens, D. Mangelings and Y. Vander Heyden

Publication Year: 2016


Abstract:

The increased interest in the separation of small peptides, proteins and chiral molecules leads to an increased demand for appropriate analytical methodologies. As a result of its separation mechanism, capillary electrophoresis (CE) is frequently used in those analyses. The more common application of CE methods therefore entails more frequent analytical method transfers (AMT). Due to the lower precision and robustness of CE methods, the instrumental differences and the larger impact of multiple parameters on the separation, the AMT of CE methods is more challenging compared to HPLC methods. In this project AMT guidelines were defined which should facilitate a successful AMT rate of CE methods, both between laboratories and instruments.In a first step, the repeatability of a chiral CE method was increased by application of a constant current. Using a constant current also generated more analogous results during inter-instrumental AMT [1]. In a second step settings that were different between instruments were selected as robustness-test parameters. The information from the robustness test and the earlier performed precision study were applied to achieve both a successful inter-laboratory and inter-instrumental transfer [2]. The developed guidelines were evaluated with a more complex separation of angiotensin II and derivatives. However loss of baseline separation occurred during this AMT and an update of the developed guidelines was needed through equalization of the electrical resistances on both instruments to overcome separation-efficiency differences [3]. In a third step, the differences concerning the detector and data-handling specifications were analysed by means of a second robustness test using the initial chiral separation as test case, and the results were incorporated in the guidelines. Finally, the occasional differences in effective length that occur with short end injection methods were studied using a separation of two strategic metals as example [4].

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