Determination of Related Substances in Donepezil Hydrochloride Tablets by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish an HPLC method for the determination of related substances in Donepezil hydrochloride tablets.METHODS:The separation was performed on AlltimaTM C18 column with mobile phase consisted of 0.01 mol?L-1 dipotassium hydrogen phosphate(3% triethylamine,pH=4.3)-methanol(6040) and flow rate of 1.0 mL?min-1.The detection wavelength was set at 271 nm and the column temperature was maintained at 35 ℃.The content of related substance was calculated by self-control with main component.RESULTS:Related substances were completely separated from the main constituent and the impurities were separated well from each other.The determination limit was 0.05 ng and the contents of related substances were 0.42%.CONCLUSION:The method is specific,sensitive and reproducible for the determination of related substances in Donepezil hydrochloride tablets.