Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine



Título del documento: Development and validation of an HPLC-UV method for accelerated stability study and pharmacokinetic analysis of venlafaxine
Revista: Brazilian Journal of Pharmaceutical Sciences
Base de datos: PERIÓDICA
Número de sistema: 000451460
ISSN: 1984-8250
Autores: 1
1
1
1
1
Instituciones: 1University of Sargodha, Department of Chemistry, Sargodha, Punjab. Pakistán
Año:
Volumen: 56
País: Brasil
Idioma: Inglés
Tipo de documento: Artículo
Enfoque: Experimental, aplicado
Resumen en inglés A reverse phase high performance liquid chromatography method has been developed and validated for accelerated stability study and determination of pharmacokinetic parameters of venlafaxine HCl. The chromatographic separation was carried out using ODS analytical column (250 × 4.6 mm i.d., 5 µm particle size). The mobile phase included acetonitrile, methanol and potassium dihydrogen phosphate buffer (30:30:40; pH 6.1) at a flow rate 1.5 mL min−1. UV-Visible detector was used at wavelength of 227 nm to monitor elutions. Retention time observed was 2.745 min. The method was validated for linearity, accuracy, precision, sensitivity and robustness. Accelerated stability study of venlafaxine HCl capsules was carried out at 40 and 50 ºC under 75% RH level. Suggested method was successfully applied for the pharmacokinetic analysis of venlafaxine hydrochloride tablets. Each of ten albino rabbits (≈ 1.2 kg each) was orally administered with 5 mg dose of venlafaxine HCl. The method was proved to be linear (R2 >0.998), accurate (98.25-99.27%), sensitive (LOD: 35ngmL−1; LOQ: 105 ng mL−1) and robust (RSD<1%). The drug showed stability at accelerated conditions of temperature and humidity. The main pharmacokinetic parameters of tested products were as follows: tmax was 2.5h, Cmax was 56.5 µg mL−1, t1/2 was 8.2 h, AUC0-36 was 845.9 µg h mL−1. The developed method is suitable to apply for quality control analysis and pharmacokinetic studies
Disciplinas: Química
Palabras clave: Química farmacéutica,
Química analítica,
Venlafaxina,
Farmacocinética,
Estabilidad química,
Cromatografía líquida de alta resolución en fase inversa (RP-HPLC)
Keyword: Medicinal chemistry,
Analytical chemistry,
Venlafaxine,
Pharmacokinetics,
Chemical stability,
Reverse phase high performance liquid chromatography
Texto completo: Texto completo (Ver HTML) Texto completo (Ver PDF)