Development and validation of a dissolution test for diltiazem hydrochloride in immediate release capsules

• Main Authors: Taciane Ferreira Mendonça, Eliézer Giannini de Barros, Gislaine Ribeiro Pereira, Magali Benjamim de Araújo, Rudy Bonfilio
• Format: Article
• Language: English
• Published: Sociedade Brasileira de Química 2011-01-01
• Series: Química Nova
• Subjects: dissolution; high performance liquid chromatography; spectrophotometry
• Online Access: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-40422011000300027&lng=en&tlng=en

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.