Development and validation of a capillary electrophoresis method for the simultaneous determination of impurities of escitalopram including the R-enantiomer

摘要: Abstract A stereospecific capillary electrophoresis assay for the simultaneous determination of related substances and enantiomeric purity escitalopram was developed by a central composite face-centered factorial design subsequently validated. Separations were carried out in 50 μm, 47/40 cm fused-silica capillary. The optimized conditions included 20 mM phosphate buffer, pH 2.5, containing 0.5 mg/ml β-cyclodextrin 22 mg/ml sulfated as background electrolyte, an applied voltage −20 kV temperature 28 °C. Salicylic acid used internal standard. validated ( R )-enantiomer citalopram enantiomers impurity citadiol range 2.5–150 μg/ml 2.5–50 μg/ml, respectively. limit detection 0.02% all compounds, quantitation 0.05%, relative to concentration 5 mg/ml. Intraday precision migration time peak area ratio 0.17–0.44% 1.64% 6.25%, Relative standard deviations interday ranged between 0.84% 1.85% case times 5.20% 9.28% ratio. bulk drug tablets. )-Citalopram S )-citadiol detected impurities.