Abstract
A capillary zone electrophoresis method has been developed for the detection of 0.1% of ( R)-levochlorpheniramine maleate in samples of ( S)-dexchlorpheniramine maleate. Using 1.5 m M carboxymethyl-β-cyclodextrin in an acidic background electrolyte, resolution values of more than 10 were obtained. Under these conditions the R-enantiomer is migrating in front of the bulk S-enantiomer. The assay was validated for linearity (2–10 μg/ml; R 2=0.9992), selectivity [( RS)-pheniramine maleate and ( RS)-brompheniramine maleate], limit of detection (0.25 μg/ml), limit of quantification (0.75 μg/ml), analytical precision (intra- and inter-day variability), repeatability of the method (RSD=5.0%) and accuracy. In samples of dexchlorpheniramine maleate from two different manufacturers, concentrations of, respectively, 0.15% and 1.95% (m/m) of levochlorpheniramine maleate were detected. The method was compared to the HPLC method described in the European Pharmacopoeia III monograph.
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