Development and validation of a dissolution test with reversed-phase liquid chromatography analysis for rupatadine in tablet dosage forms

A dissolution test for in vitro evaluation of tablet dosage forms containing 10 mg of rupatadine was developed and validated by RP-LC. A discriminatory dissolution method was established using apparatus paddle at a stirring rate of 50 rpm with 900 mL of deaerated 0.01 M hydrochloric acid. The propos...

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Bibliographic Details
Published in:Química Nova 2010, Vol.33 (5), p.1150-1154
Main Authors: Dalmora, Sérgio Luiz, Nogueira, Daniele Rubert, Calegari, Guilherme Zanini, Bergamo, Ana Cláudia, Stamm, Fernanda Pavani
Format: Article
Language:English
Subjects:
CHEMISTRY, MULTIDISCIPLINARY
dissolution test
RP-LC
rupatadine
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Summary:A dissolution test for in vitro evaluation of tablet dosage forms containing 10 mg of rupatadine was developed and validated by RP-LC. A discriminatory dissolution method was established using apparatus paddle at a stirring rate of 50 rpm with 900 mL of deaerated 0.01 M hydrochloric acid. The proposed method was validated yielding acceptable results for the parameters evaluated, and was applied for the quality control analysis of rupatadine tablets, and to evaluate the formulation during an accelerated stability study. Moreover, quantitative analyses were also performed, to compare the applicability of the RP-LC and the LC-MS/MS methods.
ISSN:0100-4042
1678-7064
1678-7064
DOI:10.1590/S0100-40422010000500028