Validation of a stability-indicating RP-HPLC method for the determination of entecavir in tablet dosage form.
J AOAC Int
; 93(2): 523-30, 2010.
Article
em En
| MEDLINE
| ID: mdl-20480899
An RP-HPLC method was validated for the determination of entecavir in tablet dosage form. The HPLC method was carried out on a Gemini C18 column (150 x 4.6 mm id) maintained at 30 degrees C. The mobile phase consisted of acetonitrile-water (95 + 5, v/v)/potassium phosphate buffer (0.01 M, pH 4; 9 + 91, v/v) pumped at a flow rate of 1.0 mL/min. Photodiode array detection was at 253 nm. The chromatographic separation was obtained with a retention time of 4.18 min, and the method was linear in the range of 0.5-200 microg/mL (r2 = 0.9998). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients and an increase of the cytotoxicity only by the basic condition. The accuracy was 101.19%, with bias lower than 1.81%. The LOD and LOQ were 0.39 and 0.5 microg/mL, respectively. Method validation demonstrated acceptable results for precision and robustness. The proposed method was applied for the analysis of tablet formulations, to improve QC and assure therapeutic efficacy.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Antivirais
/
Comprimidos
/
Cromatografia Líquida de Alta Pressão
/
Tecnologia Farmacêutica
/
Guanina
Tipo de estudo:
Prognostic_studies
Idioma:
En
Revista:
J AOAC Int
Ano de publicação:
2010
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Reino Unido