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

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ID: 130433
2010
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Abstract
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.
Reference Key
dalmora2010qumicadevelopment Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Sérgio Luiz Dalmora;Daniele Rubert Nogueira;Guilherme Zanini Calegari;Ana Cláudia Bergamo;Fernanda Pavani Stamm
Journal greece and rome
Year 2010
DOI
10.1590/S0100-40422010000500028
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