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Direct Enantiomeric Purity Determination of Acetyl-L-carnitine by LC with a Ligand-Exchange Chiral Stationary Phase
Authors:M Kagawa  Y Machida  H Nishi  J Haginaka
Institution:1. Analytical Development Laboratories, Tanabe Seiyaku Co. Ltd, 16-89, Kashima 3-chome, Yodogawa-ku, Osaka, 532-8505, Japan
2. Faculty of Pharmaceutical Sciences, Mukogawa Women’s University, 11-68, Koshien Kyuban-cho, Nishinomiya, Hyogo, 663-8179, Japan
Abstract:A direct HPLC method for the determination of acetyl-D-carnitine in acetyl-L-carnitine was investigated. The enantiomers were successfully separated on a SUMICHIRAL OA-6100 column, which has a ligand-exchange type of chiral moiety. The mobile phase consisted of an aqueous solution of copper (II) sulfate and sodium perchlorate. Successful enantioseparation seems to be achieved through the formation of not only the complex with copper (II) ion but also by ion-pairing with the perchlorate ion, because no enantioseparation was observed with the usual copper (II) mobile phase alone. Employing 2 mM aqueous CuSO4 solution containing 500 mM NaClO4, the enantiomers of acetylcarnitine eluted in the order of D- and L-forms within 15 min with R s = 1.92 and α = 1.11. The obtained LOQ and LOD values were 0.15 and 0.1%, respectively. The validated results were satisfactory for a practical quality control method for the enantiomeric purity determination of acetyl-L-carnitine.
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