Chinese Journal of Chromatography ›› 2012, Vol. 30 ›› Issue (12): 1265-1270.DOI: 10.3724/SP.J.1123.2012.07035

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Chiral separation of benzamide antipsychotics and determination of their enantiomers by high performance liquid chromatography

WANG Liping, FAN Huajun*, WU Kunhong, PENG Xiaosheng, JIANG Zitao, ZANG Linquan   

  1. College of Pharmacy, Guangdong Pharmaceutical University, Guangzhou 510006, China
  • Received:2012-07-21 Revised:2012-09-19 Online:2012-12-28 Published:2012-12-19

Abstract: A new method of the chiral separation of three drugs such as sulpiride, amisulpride and mosapride was developed on the chiral stationary phase of amylose-tris-(5-chloro-2-methyl- phenylcarbamate) (ACMPC) by high performance liquid chromatography. The chromatographic behaviors of enantiomers of the three drugs were investigated in the mobile phases consisted of ethanol and n-hexane (containing 0.1%(v/v) diethylamine). The chromatographic conditions including the composition of the mobile phase, additives and temperature were further optimized for the chiral separation. The mechanism of racemic resolution for the mentioned drugs is discussed thermodynamically and structurally. The results indicated that these three chiral drugs could be separated on an ACMPC column under the optimum conditions, and their chiral resolutions were improved up to more than 1.5. The chromatographic parameters such as the retention factor k, separation factor α are presented, and the thermodynamic functions were calculated for the separation of the enantiomers of the three drugs. The method has been successfully applied to the determination of the enantiomers of the three drugs in tablets and blood serum. It is simple, reliable and accurate.

Key words: amisulpride, chiral separation, drugs, mosapride, sulpiride, high performance liquid chromatography (HPLC)