Development and Validation of a Capillary Zone Electrophoresis Method for the Quantitative Determination of Atypical Antipsychotic Risperidone in Pharmaceutical Dosage forms
Fernanda N.I. Nagase, Aline E. Asato, Pedro López Garcia, Angel A. Gaona Galdos, Maria Ines R.M. Santoro, Erika R.M. Kedor-Hackmann and María Segunda Aurora-Prado
Affiliation: Faculty of Pharmaceutical Sciences, University of Sao Paulo, Av. Prof. Lineu Prestes 580, 05508-000 Sao Paulo, SP, Brazil.
A rapid and simple analytical capillary zone electrophoresis (CZE) method has been developed and validated
for quantitative determination of atypical antipsychotic drug risperidone in commercially available film-coated tablets.
CZE was performed in an uncoated fused-silica capillary 40.2 cm total length x 75 µm i.d. (30 cm effective length) using
a 20 mmol mL-1 sodium phosphate solution containing 0.1% triethylamine (v/v), pH 2.5 adjusted with ortho-phosphoric
acid as background electrolyte. The applied voltage was +28 kV and UV detection at 236 nm, nitrazepam was used as internal
standard (IS). Under these conditions, the separation of risperidone was achieved in less than 2.5 min. The method
was validated and response was found to be linear with determination coefficient better than 0.999. The repeatability and
intermediate precision expressed as relative standard deviation were less than 1.5 %. The accuracy, resulting from recovery
experiments, was between 98.84 and 101.24 %. The active pharmaceutical ingredient was subjected to acid, alkaline
and neutral hydrolysis and oxidative stress conditions. No interference from degradation products and also from tablet excipients
was observed. The method was simple, precise and fast and could be successfully applied for determination of
risperidone in pharmaceutical dosage forms and can be used for routine analysis in pharmaceutical industries. Furthermore,
the method can be used as a stability-indicating method.
Keywords: Capillary zone electrophoresis, method validation, neuroleptic drug, pharmaceuticals, quantitative determination,
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