artículo científico
Validation of an analytical method for a comparative profiles of in vitro therapeutic equivalence of immediate release tablets of chlorpheniramine maleate 4 mg
Fecha
2019Autor
Madrigal Redondo, German
Tromp, S.
Masís Alpízar, S.
Chavarría Rojas, Marianela
Sibaja Rodríguez, Santiago
Acuña Cubillo, C.
Institución
Resumen
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.