title: RP-HPLC analytical method development and optimization for quantification of donepezil hydrochloride in orally disintegrating tablet.
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 (50:30:20, 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 μg/mL to 16 μg/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.
authors.affiliation: Department of Pharmaceutical Technology, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia.
authors.forename: Kai Bin
authors.initials: KB
authors.lastname: Liew
authors.forename: Kok Khiang
authors.initials: KK
authors.lastname: Peh
authors.forename: Yvonne Tze
authors.initials: YT
authors.lastname: Fung Tan
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D000284:Administration, Oral; D002021:Buffers; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D056148:Chromatography, Reverse-Phase / Q000592:standards; D000077265:Donepezil; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007189:Indans / Q000008:administration & dosage / Q000032:analysis*; D057230:Limit of Detection; D000432:Methanol / Q000737:chemistry; D010756:Phosphoric Acids / Q000737:chemistry; D010880:Piperidines / Q000008:administration & dosage / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D012995:Solubility; D012997:Solvents / Q000737:chemistry; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards; D013997:Time Factors
chemical_list: D000097:Acetonitriles; D002021:Buffers; D007189:Indans; D010756:Phosphoric Acids; D010880:Piperidines; D012997:Solvents; D013607:Tablets; D000077265:Donepezil; C030242:phosphoric acid; D000432:Methanol; C032159:acetonitrile