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
Artículo
en Inglés
| 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 (4456, 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:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Diltiazem
/
Cromatografía Líquida de Alta Presión
/
Estudio de Validación
Idioma:
Inglés
Revista:
Braz. J. Pharm. Sci. (Online)
Asunto de la revista:
Farmacologia
/
Teraputica
/
Toxicologia
Año:
2017
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Universidade Federal de Minas Gerais/BR
/
Universidade Federal do Rio Grande do Norte/BR
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