Optimization and validation of an enantioselective method for a chiral drug with eight stereo-isomers in capillary electrophoresis.
Highly selective capillary electrophoresis (CE) screening methods were applied to find a satisfactory separation of a chiral drug with eight stereoisomeric compounds. The initial separation conditions were further optimized using response surface modelling by applying a Box-Behnken experimental design. This approach resulted in a rapid and efficient optimization of the buffer concentration, the concentration of two cyclodextrins, and the run voltage, in order to obtain final separation conditions of the method. Further optimization and validation of the system in terms of sensitivity and robustness resulted in a method that is suitable for quality control release purposes.
Jimidar
M Ilias
MI
Johnson & Johnson, Pharmaceutical Research & Development, Global Analytical Development, Beerse, Belgium. ijimidar@prdbe.jnj.com
Vennekens
Tom
T
Van Ael
Willy
W
Redlich
Dirk
D
De Smet
Maurits
M
D003505:Cyclodextrins; D019075:Electrophoresis, Capillary / Q000379:methods* / Q000706:statistics & numerical data; D007202:Indicators and Reagents; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000302:isolation & purification*; D012996:Solutions; D013237:Stereoisomerism
D003505:Cyclodextrins; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations; D012996:Solutions