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

AUTOR(ES)

Dalmora, Sérgio Luiz, Nogueira, Daniele Rubert, Calegari, Guilherme Zanini, Bergamo, Ana Cláudia, Stamm, Fernanda Pavani

FONTE

Química Nova

DATA DE PUBLICAÇÃO

2010

RESUMO

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.

Documentos Relacionados

• RNA analysis by ion-pair reversed-phase high performance liquid chromatography
• Determination of free urinary cortisol in cushing's syndrome using reversed-phase high performance liquid chromatography
• Disposable reversed-phase chromatography columns for improved detection of carboxylic acids in body fluids by electron-capture gas-liquid chromatography.
• Quantitative reversed-phase high performance liquid chromatographic determination of major and modified deoxyribonucleosides in DNA.
• Development and validation of spectroscopic methods for simultaneous estimation and dissolution of ofloxacin and ornidazole in tablet dosage forms