Enantiomeric separation and determination of the enantiomeric impurity of armodafinil by capillary electrophoresis with sulfobutyl ether-β-cyclodextrin as chiral selector.
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.
Department of Analytical Chemistry, China Pharmaceutical University, Nanjing 211198, China.
Wei
W
Wang
Suyun
S
Xiang
Xiaojuan
X
Zhou
Yibing
Y
Ji
Bingren
B
Xiang
D001559:Benzhydryl Compounds / Q000737:chemistry / Q000302:isolation & purification*; D000697:Central Nervous System Stimulants / Q000737:chemistry / Q000302:isolation & purification*; D019075:Electrophoresis, Capillary / Q000592:standards; D006863:Hydrogen-Ion Concentration; D057230:Limit of Detection; D000432:Methanol / Q000737:chemistry; D000077408:Modafinil; D012015:Reference Standards; D015203:Reproducibility of Results; D059629:Signal-To-Noise Ratio; D012997:Solvents / Q000737:chemistry; D013237:Stereoisomerism; D047392:beta-Cyclodextrins / Q000737:chemistry*
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D012997:Solvents; D047392:beta-Cyclodextrins; C093196:SBE4-beta-cyclodextrin; D000077408:Modafinil; D000432:Methanol