Electrophoresis · 1999 · 28 citations · 13 references
PharmacyPharmaceutical AnalysisPharmaceuticsChromatographic AnalysisElectroanalytical MethodsMass Spectrometric AnalysisBioanalytical Method ValidationChiral ChromatographyChiral Impurity AnalysisChromatographic Analysis Of PharmaceuticalsChromatographyInstrumental AnalysisCapillary ElectrophoresisCapillary Electrophoresis Method DevelopmentChiral Capillary ElectrophoresisChiral Purity TestingElectroosmotic FlowEnantiomeric ImpuritiesEnantiomeric Impurity AnalysisEnantiomeric Purity Assessment
The use of a chirally selective capillary electrophoresis method is reported for the enantioselective purity determination of propranolol drug substance. The method employed a combination of both charged and neutral cyclodextrin. An internally coated capillary was used to suppress electroosmotic flow and potential peak tailing. The method was capable of monitoring below 0.1% m/m of the undesired impurity. Acceptable validation data was also obtained for recovery, linearity, and for both short and long-term injection precision.
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