Chiral capillary electrophoretic analysis of the enantiomeric purity of a pharmaceutical compound using sulfated beta-cyclodextrin.
A practical chiral capillary electrophoresis method using randomly sulfated beta-cyclodextrin was developed for the quantitative determination of the chiral purity of a pharmaceutical compound. A systematic method development approach was conducted by modifying selected parameters such as the concentration of the chiral selectors, buffer pH, organic modifiers, buffer concentrations and type, temperature and applied voltage. The results of the investigation permitted an improved understanding of the separation mechanism. Two facile strategies for the reversal of the enantiomer elution order are also described. The optimized method was validated in terms of variability of the chiral selector, linearity, sensitivity, accuracy, recovery, ruggedness, and precision.
Zhou
L
L
Merck Research Laboratories, Merck and Co. Inc., Rahway, NJ 07065, USA.
Johnson
B D
BD
Miller
C
C
Wyvratt
J M
JM
D002021:Buffers; D003505:Cyclodextrins / Q000737:chemistry*; D019075:Electrophoresis, Capillary / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000302:isolation & purification*; D015203:Reproducibility of Results; D013237:Stereoisomerism; D013464:Sulfuric Acids / Q000737:chemistry; D013696:Temperature; D047392:beta-Cyclodextrins
D002021:Buffers; D003505:Cyclodextrins; D004364:Pharmaceutical Preparations; D013464:Sulfuric Acids; D047392:beta-Cyclodextrins; C031215:betadex