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Molecules 2012, 17(1), 303-314; doi:10.3390/molecules17010303

Enantiomeric Separation and Determination of the Enantiomeric Impurity of Armodafinil by Capillary Electrophoresis with Sulfobutyl Ether-β-cyclodextrin as Chiral Selector

1
Department of Analytical Chemistry, China Pharmaceutical University, Nanjing 211198, China
2
College of Life Science, Nanjing Normal University, Nanjing 210046, China
3
Key Laboratory of Drug Quality Control and Pharmacovigilance (Ministry of Education), China Pharmaceutical University, Nanjing 210009, China
4
Center for Instrument Analysis, China Pharmaceutical University, Nanjing, 210009, China
*
Author to whom correspondence should be addressed.
Received: 16 December 2011 / Revised: 27 December 2011 / Accepted: 28 December 2011 / Published: 30 December 2011
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Abstract

A selective capillary electrophoresis method using sulfobutyl ether-β-cyclodextrin as a chiral selector was developed and validated for the determination of the enantiomeric impurity of (R)-modafinil, i.e., armodafinil. Several parameters were optimized for a satisfactory enantioresolution, including the type and concentration of chiral selector and organic modifier, pH of background electrolyte (BGE), capillary temperature. The finally adopted condition was: 20 mmol/L phosphate buffer at pH 7.5, containing 20 mmol/L sulfobutyl ether-β-cyclodextrin and 20% methanol, at temperature of 25 °C. A good resolution of 3.3 for the two enantiomers of modafinil was achieved by applying the optimal conditions. The limit of detection (LOD) and limit of quantification (LOQ) of (S)-modafinil were 1.25 μg/mL and 2.50 μg/mL, respectively. The established method was also proven to display good selectivity, repeatability, linearity and accuracy. Finally, the method was used to investigate the enantiomeric purity of armodafinil in bulk samples.
Keywords: capillary electrophoresis; armodafinil; enantiomeric impurity; sulfobutyl ether-β-cyclodextrin capillary electrophoresis; armodafinil; enantiomeric impurity; sulfobutyl ether-β-cyclodextrin
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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MDPI and ACS Style

Wang, W.; Xiang, S.; Zhou, X.; Ji, Y.; Xiang, B. Enantiomeric Separation and Determination of the Enantiomeric Impurity of Armodafinil by Capillary Electrophoresis with Sulfobutyl Ether-β-cyclodextrin as Chiral Selector. Molecules 2012, 17, 303-314.

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