Validación del método analítico por espectrofotometríauv/vispara la cuantificación de risperidona en tabletas 2 mg

• Autores: Escobar Vásquez, Gladys Fiorella, Sánchez Benites, Edson Diego
• Formato: tesis de grado
• Fecha de Publicación: 2013
• Institución: Universidad Nacional de Trujillo
• Repositorio: UNITRU-Tesis
• Lenguaje: español
• OAI Identifier: oai:dspace.unitru.edu.pe:20.500.14414/3930
• Enlace del recurso: https://hdl.handle.net/20.500.14414/3930
• Nivel de acceso: acceso abierto
• Materia: Validación, Cuantificación, Risperidona, Espectrofotometría, Metanol

The analytical method validation is an integral part of the quality control system, since it gives reliability to the analytical results obtained in a laboratory, to ensure that a drug comply established equality parameters. We present the validation of an analytical method for quantification of 2 mg Risperidone tablets, using the technique of spectrophotometry UV / VIS proposed by the authors G. Alagumanivasagam, A. Anton Smith, Department of Pharmacy, Annamalai University in India.For the analysis of 2 mg Risperidone tablets from three pharmaceutical laboratories (Farmindustria, Marfan and Medrock) methanol was used as solvent and was measured at a wavelength of maximum absorbance of 278 nm.The samples were subjected to acid degradation, alkaline oxidation and thermolysis, obtaining interference less than 2%. The linearity test method showed a correlation coefficient of 0.9998910. For accuracy, the recovery rate was 99.65%, for the Cochran's Gtable less than Gexp was obtained (0.5330 <0.6830) and the Student t test statistic was obtained ttable less than texp (0.9028 <2.1448), for which accuracy complied according to their respective specifications. For the repeatability of the system CV of 0.121% was yielded. For the repeatability of the method CV of 0.250% was yielded. For intermediate precision CV between an analyst and the other was of 1.50%.The validation parameters determined lead to a validated analytical method proposed by the authors.