Development and validation of a stability indicating HPLC method to determine diltiazem hydrochloride in tablets and compounded capsules
Braz. J. Pharm. Sci. (Online)
;
53(3): e00041, 2017. tab, graf
Artigo
em Inglês
| LILACS
| ID: biblio-889383
ABSTRACT
ABSTRACT A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min-1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust, and was adequate for stability studies and routine quality control analyses of DTZ in tablets and compounded capsules.
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Diltiazem
/
Cromatografia Líquida de Alta Pressão
/
Estudo de Validação
Idioma:
Inglês
Revista:
Braz. J. Pharm. Sci. (Online)
Assunto da revista:
Farmacologia
/
Teraputica
/
Toxicologia
Ano de publicação:
2017
Tipo de documento:
Artigo
País de afiliação:
Brasil
Instituição/País de afiliação:
Universidade Federal de Minas Gerais/BR
/
Universidade Federal do Rio Grande do Norte/BR
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