Validación de la técnica analítica por cromatografía líquida de alta performance (HPLC) para la cuantificación de Loratadina y Dexametasona en tabletas

• Autor: López Alvarado, Luis Angel
• Formato: tesis de grado
• Fecha de Publicación: 2015
• Institución: Universidad Nacional de Trujillo
• Repositorio: UNITRU-Tesis
• Lenguaje: español
• OAI Identifier: oai:dspace.unitru.edu.pe:20.500.14414/15869
• Enlace del recurso: https://hdl.handle.net/20.500.14414/15869
• Nivel de acceso: acceso abierto
• Materia: Loratadina; Dexametasona; validación; Especificidad; Linealidad; Precisión; Exactitud.

This report aims to present documentary evidence that the results produced are reliable, consistent and reproducible in the conditions. Was proposed analytical method validation by High Performance Liquid Chromatography of Dexamethasone and Loratadine Tablets Coated, evaluating parameters such as specificity or selectivity, linearity, precision, accuracy and stability in order to comply with the requirements of U.S. Pharmacopeia (USP), International Conference on Harmonization Tripartite (ICH) and recommendations of the Spanish Association of Pharmaceutical Industry (AEFI). Once the defined working conditions, the respective analysis for evaluating the validation parameters were performed. It was demonstrated by the experimental design, analytical methodology that meets the characteristic that is linear, because it was obtained r = 0.999376; r2 = 0.998752 for Dexamethasone r = 0.999591; r2 = 0.999182 for Loratadine; necessary, the RSD (Repeatability method) = 0.80%; RSD (intermediate precision) = 0.97% for dexamethasone and RSD (Assay Method) = 0.71%; RSD (intermediate precision) = 0.83%, for Loratadine; precisely for having 99.76% recovery for Dexamethasone and 99.56% recovery for Loratadine; and is selective for the analyte under study as evidenced no interference and finally check their stability over the period evaluated. Therefore we conclude that the validated method is reliable, consistent and can be used in the lab for analysis