Abstract
VALIDATION OF AN ANALYTICAL METHOD FOR A COMPARATIVE PROFILES OF IN VITRO THERAPEUTIC EQUIVALENCE OF IMMEDIATE RELEASE TABLETS OF CHLORPHENIRAMINE MALEATE 4 MG

Madrigal-Redondo G.*, Tromp S., Masis-Alpizar S., Chavarría-Rojas M. and Sibaja-Rodríguez S. Acuña-Cubillo C.

ABSTRACT

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.

Keywords: Chlorpheniramine maleate, pharmaceutical equivalence, validation, analytical methods.


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