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

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.