Experimentally designed, validated hplc simultaneous determination of pridinol and diclofenac in their combined pharmaceutical formulations, which allows limiting diclofenac related compound A

The development and validation of an HPLC method for the determination of pridinol and diclofenac in their combined formulations and the simultaneous limit testing of diclofenac related compound A is described. The separation was performed on a C18 column. Experimental design and response surface st...

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Detalles Bibliográficos
Autores: Vignaduzzo, Silvana Edit, Castellano, Patricia Margarita, Kaufman, Teodoro Saul
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2010
País:Argentina
Institución:Consejo Nacional de Investigaciones Científicas y Técnicas
Repositorio:CONICET Digital (CONICET)
Idioma:inglés
OAI Identifier:oai:ri.conicet.gov.ar:11336/133263
Acceso en línea:http://hdl.handle.net/11336/133263
Access Level:acceso abierto
Palabra clave:DICLOFENAC
DICLOFENAC RELATED COMPOUND A
EXPERIMENTAL DESIGN
HPLC DETERMINATION
PRIDINOL
VALIDATION
https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
Descripción
Sumario:The development and validation of an HPLC method for the determination of pridinol and diclofenac in their combined formulations and the simultaneous limit testing of diclofenac related compound A is described. The separation was performed on a C18 column. Experimental design and response surface strategies were employed for optimizing detection wavelength (225nm) and mobile phase composition [MeOH:2-propanol:phosphate buffer (50mM, pH 5.5), 48:9:43 (v/v/v), 1mLmin-1], and for validation purposes. The method was successfully applied to the quality control of commercial brands of tablets and capsules. Found impurity levels were below 0.1% (LOQ=0.02%). Stressed samples were also evaluated.