title: New gradient high-performance liquid chromatography method for determination of donepezil hydrochloride assay and impurities content in oral pharmaceutical formulation.
abstract: A new gradient HPLC method has been developed and validated for the determination of both assay and related substances of donepezil hydrochloride in oral pharmaceutical formulation. Different kinds of columns and gradient elution programs were tested in order to achieve satisfactory separation between the active substance, four impurities and an interfering excipient used in the formulation. The best results were obtained using an Uptisphere ODB C-18 column 250 mm x 4.6 mm, 5 microm, UV detection at 270 nm and a gradient elution of phosphate buffer (0.005 M, pH 3.67) and methanol as the mobile phase. The method was validated with respect to linearity, precision, accuracy, specificity and robustness. It was also found to be stability indicating, and therefore suitable for the routine analysis of donepezil hydrochloride and related substances in the pharmaceutical formulation.
authors.affiliation: R&D Laboratory, Genepharm S.A. Pharmaceutical Company, 18 km Marathon Avenue, 15351 Athens, Greece. s.kafkala@genepharm.com
authors.forename: Stella
authors.initials: S
authors.lastname: Kafkala
authors.forename: Stella
authors.initials: S
authors.lastname: Matthaiou
authors.forename: Pandora
authors.initials: P
authors.lastname: Alexaki
authors.forename: Morfis
authors.initials: M
authors.lastname: Abatzis
authors.forename: Antonios
authors.initials: A
authors.lastname: Bartzeliotis
authors.forename: Maria
authors.initials: M
authors.lastname: Katsiabani
mesh_terms: D000284:Administration, Oral; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000077265:Donepezil; D004340:Drug Contamination / Q000517:prevention & control; D007189:Indans / Q000032:analysis* / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000032:analysis* / Q000737:chemistry; D010880:Piperidines / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
chemical_list: D007189:Indans; D004364:Pharmaceutical Preparations; D010880:Piperidines; D000077265:Donepezil