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

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

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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; doi:10.3390/moleculeOPEN ACCESS molecules ISSN 1420-3049 /journal/molecules Article Enantiomeric Separation and Determination of the Enantiomeric Impurity of Armodafinil by Capillary Electrophoresis with Sulfobutyl Ether-β-cyclodextrin as Chiral Selector Wei Wang 1, Suyun Xiang 2, Xiaojuan Zhou 1, Yibing Ji 1 and Bingren Xiang 3,4,* 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; E-Mail: xiangcpu@; Tel./Fax: +86-25-8618-5150. Received: 16 December 2011; in revised form: 27 December 2011 / Accepted: 28 December 2011 / Published: 30 December 2011 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 selectivit