RP-HPLC analytical method development and optimization for quantification of donepezil hydrochloride in orally disintegrating tablet

Pak J Pharm Sci. 2013 Sep;26(5):961-6.

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.

MeSH terms

  • Acetonitriles / chemistry
  • Administration, Oral
  • Buffers
  • Calibration
  • Chemistry, Pharmaceutical
  • Chromatography, High Pressure Liquid* / standards
  • Chromatography, Reverse-Phase* / standards
  • Donepezil
  • Drug Stability
  • Hydrogen-Ion Concentration
  • Indans / administration & dosage
  • Indans / analysis*
  • Limit of Detection
  • Methanol / chemistry
  • Phosphoric Acids / chemistry
  • Piperidines / administration & dosage
  • Piperidines / analysis*
  • Reference Standards
  • Reproducibility of Results
  • Solubility
  • Solvents / chemistry
  • Tablets
  • Technology, Pharmaceutical / methods*
  • Technology, Pharmaceutical / standards
  • Time Factors

Substances

  • Acetonitriles
  • Buffers
  • Indans
  • Phosphoric Acids
  • Piperidines
  • Solvents
  • Tablets
  • Donepezil
  • phosphoric acid
  • Methanol
  • acetonitrile