Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules
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Data
2011-01-01
Autores
Mendonça, Taciane Ferreira
Barros, Eliézer Giannini de
Pereira, Gislaine Ribeiro
Araújo, Magali Benjamim de
Bonfilio, Rudy [UNESP]
Título da Revista
ISSN da Revista
Título de Volume
Editor
Sociedade Brasileira de Química
Resumo
This work describes the development and validation of a dissolution test for 60 mg of diltiazem hydrochloride in immediate release capsules. The best dissolution in vitro profile was achieved using potassium phosphate buffer at pH 6.8 as the dissolution medium and paddle as the apparatus at 50 rpm. The drug concentrations in the dissolution media were determined by UV spectrophotometry and HPLC and a statistical analysis revealed that there were significant differences between HPLC and spectrophotometry. This study illustrates the importance of an official method for the dissolution test, since there is no official monograph for diltiazem hydrochloride in capsules.
Descrição
Palavras-chave
dissolution, high performance liquid chromatography, spectrophotometry
Como citar
Química Nova. Sociedade Brasileira de Química, v. 34, n. 3, p. 520-526, 2011.