A new HPLC method to determine Donepezil hydrochloride in tablets.
A HPLC stability-indicating assay for Donepezil hydrochloride in tablets was developed and validated. Donepezil hydrochloride is a reversible inhibitor of acetylcholinesterase, indicated for the treatment of mild to moderate dementia of the Alzheimer's type. The HPLC method was performed with a reversed phase C18 column, detection at 268 nm and a mixture of methanol, phosphate buffer 0.02 M and triethylamine (50:50:0.5) as mobile phase. Typical retention time for Donepezil was 9 min. The method was statistically validated for linearity, accuracy, precision and selectivity following ICH recommendations. Due to its simplicity and accuracy, the method can be used for routine quality control analysis.
Pappa
Horacio
H
Cátedra de Control de Calidad de Medicamentos, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junín 956, 1113, Buenos Aires, Argentina.
Farrú
Romina
R
Vilanova
Paula Otaño
PO
Palacios
Marcelo
M
Pizzorno
María Teresa
MT
D002851:Chromatography, High Pressure Liquid / Q000379:methods; D000077265:Donepezil; D004355:Drug Stability; D007189:Indans / Q000032:analysis*; D010880:Piperidines / Q000032:analysis*; D015203:Reproducibility of Results; D013607:Tablets / Q000032:analysis
D007189:Indans; D010880:Piperidines; D013607:Tablets; D000077265:Donepezil