Validation of an analytical method for a comparative profiles of in vitro therapeutic equivalence of immediate release tablets of chlorpheniramine maleate 4 mg

 

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Detalles Bibliográficos
Autores: Madrigal Redondo, German, Tromp, S., Masís Alpízar, S., Chavarría Rojas, Marianela, Sibaja Rodríguez, Santiago, Acuña Cubillo, C.
Formato: artículo original
Fecha de Publicación:2019
Descripción:The present study was carried out with the purpose of validating an analytical method for the quantification of the immediate release of tablets of chlorpheniramine maleate 4 mg and the determination or the dissolved percentage of them in three buffers, using a UV-Vis spectrophotometer for the analysis of these data. The analytical results show that the method complies with the parameters of linearity, precision and accuracy. The calibration curve of each medium was carried out in a concentration range of 2-14 μg / mL, linearity was demonstrated in each medium, considering the following criteria: homoscedasticity, variance analysis, correlation coefficient and random distribution data; precision was evaluated in terms of repeatability and intermediate precision; and finally, the accuracy was evaluated by the determination of recovery percentage. Therefore, the methodology complies with the specifications established by USP 40.
País:Kérwá
Institución:Universidad de Costa Rica
Repositorio:Kérwá
Lenguaje:Inglés
OAI Identifier:oai:kerwa.ucr.ac.cr:10669/85359
Acceso en línea:https://storage.googleapis.com/journal-uploads/ejbps/article_issue/volume_6_march_issue_3/1551775559.pdf
https://hdl.handle.net/10669/85359
Palabra clave:Chlorpheniramine maleate
Pharmaceutical equivalence
Validation
Analytical methods