Method development in liquid chromatography with a charged cyclodextrin additive for chiral resolution of rac-amlodipine utilising a central composite design

Chirality
P K OwensJ C Berridge

Abstract

A negatively charged derivative of beta-cyclodextrin, sulphobutyl ether-beta-cyclodextrin (SBE-beta-CD), was examined as a chiral mobile phase additive in reversed-phase high-performance liquid chromatography for the enantiomeric resolution of the calcium channel blocker rac-amlodipine. Theoretical and practical aspects are discussed for setting up a central composite design applicable to any analytical method. These include the correct location of factor points for maintaining orthogonality within the design and the augmentation of centrepoint experiments to allow a larger factor space by increasing the distance of axial star points. Optimised separation was achieved using a reverse-phase column with eluent comprising: acetonitrile (ACN)-potassium dihydrogen phosphate (pH 3.93) containing 2.66 mM SBE-beta-CD (26.5:73.5% v/v) at a flow rate of 1.0 ml/min. This yielded a Kaiser peak separation index, Pi = 0.96, at tR2 = 52 min with satisfactory reproducibility, relative standard deviation values: tR1, 0.39%; tR2, 0.47% (n = 5). These experimental results were in excellent agreement with those predicted by the SAS software package for a chromatographic response function model. Multiple regression analysis in four dimensions, with...Continue Reading

Citations

Jun 22, 1999·Biomedical Chromatography : BMC·J Bojarski, H Y Aboul-Enein
Oct 25, 2000·Journal of Chromatography. a·A M Siouffi, R Phan-Tan-Luu
Feb 24, 2001·Journal of Chromatography. a·K B Lipkowitz
Jan 25, 2003·Journal of Biochemical and Biophysical Methods·Nobuo Inotsume, Masahiro Nakano
Sep 25, 2003·Bioorganic & Medicinal Chemistry Letters·Hon-Wah ManGeorge W Muller

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