RP-HPLC analytical method development and optimization for quantification of donepezil hydrochloride in orally disintegrating tablet
Pakistan Journal of Pharmaceutical Sciences. 2013; 26 (5): 961-966
em Inglês
| IMEMR
| ID: emr-138416
ABSTRACT
An easy, fast and validated RV-HPLC method was invented to quantify donepezil hydrochloride in drug solution and orally disintegrating tablet. The separation was carried out using reversed phase C-18 column [Agilent Eclipse Plus C-18] with UV detection at 268 nm. Method optimization was tested using various composition of organic solvent. The mobile phase comprised of phosphate buffer [0.01M], methanol and acetonitrile [503020, v/v] adjusted to pH 2.7 with phosphoric acid [80%] was found as the optimum mobile phase. The method showed intraday precision and accuracy in the range of 0.24% to -1.83% and -1.83% to 1.99% respectively, while interday precision and accuracy ranged between 1.41% to 1.81% and 0.11% to 1.90% respectively. The standard calibration curve was linear from 0.125 micro g/mL to 16 micro g/mL, with correlation coefficient of 0.9997 +/- 0.00016. The drug solution was stable under room temperature at least for 6 hours. System suitability studies were done. The average plate count was > 2000, tailing factor <1, and capacity factor of 3.30. The retention time was 5.6 min. The HPLC method was used to assay donepezil hydrochloride in tablet and dissolution study of in-house manufactured donepezil orally disintegrating tablet and original Aricept
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Índice:
IMEMR (Mediterrâneo Oriental)
Assunto principal:
Acetonitrilas
/
Ácidos Fosfóricos
/
Soluções Tampão
/
Calibragem
/
Administração Oral
/
Cromatografia Líquida de Alta Pressão
/
Tecnologia Farmacêutica
/
Metanol
/
Estabilidade de Medicamentos
/
Cromatografia de Fase Reversa
Idioma:
Inglês
Revista:
Pak. J. Pharm. Sci.
Ano de publicação:
2013
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