Title: Development and validation of a chiral capillary electrophoresis method for assay and enantiomeric purity control of pramipexole
Authors: Deng, Xiaolan
Hai, Xin
Vervoort, Ruud
Pamperin, Dirk
Adams, Erwin
Van Schepdael, Ann # ×
Issue Date: Nov-2011
Publisher: Wiley-VCH Verlag GMBH
Series Title: Journal of Separation Science vol:34 issue:21 pages:3070-3076
Article number: 10.1002/jssc.201100444
Abstract: A rapid method for the enantioseparation of pramipexole and its R-enantiomer has been developed by capillary electrophoresis. The influence of chemical and instrumental parameters was investigated including the type and concentration of chiral selectors, buffer composition and pH, co-ions, applied voltage, capillary length and temperature. Optimal separation conditions were obtained using a 50 mM phosphate buffer (pH 2.8) containing 25 mM carboxymethyl-β-cyclodextrin on a fused-silica capillary. Online UV detection was performed at 262 nm. A voltage of 25 kV was applied, and the capillary temperature was kept at 25°C. Hydrodynamic injection was performed at 3.45 kPa for 5.0 s. The separation of enantiomers was achieved in <6.5 min. The method was further validated in terms of stability of solutions, selectivity, linearity (both pramipexole and R-enantiomer, R(2) >0.995), LOD and LOQ (0.91 and 2.94 μg/mL, respectively), repeatability (RSD<1.5%) and accuracy (pramipexole, 100.4%; R-enantiomer, 100.5%). The proposed method was then applied to two kinds of pramipexole dihydrochloride monohydrate commercially available tablets, immediate release tablets (1.50 and 0.125 mg) and sustained release tablets (0.52 mg), to quantify the main component in the tablets. The amount of distomer could be quantified in bulk sample materials.
ISSN: 1615-9306
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Pharmaceutical Analysis
× corresponding author
# (joint) last author

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