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

Author(s)
Kai Bin Liew Department of Pharmaceutical Technology, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia
Kok Khiang Peh School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia
Yvonne Tze Fung Tan Department of Pharmaceutical Technology, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia
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
Publication Details
Page(s) 961-966
DOI DOI not available
Published Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 26, Issue: 5, Year: 2013

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