N. Jagadeesh, Y. RavindraKumara, A. Jayashreeb
Mar 31, 2015
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Journal
Journal of Pharmacy Research
Abstract
Donepezil hydrochloride is a reversible inhibitor of the enzyme acetyl cholinesterase. During the process development of donepezil hydrochloride at lab scale, we observed an unknown impurity at levels 0.05-0.2% in a simple isocratic reversed phase high performance liquid chromatography (HPLC) analysis with the known potential impurities. This new unknown impurity was isolated using preparative liquid chromatography. Based on the complete spectral analysis, this new impurity was designated as 2-((1-benzylpiperidin-4-yl)methyl)-2-((4-((5,6dimethoxy-1-oxo-2,3-dihydro-1H-inden-2-yl)methyl)piperidin-1-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one (dimer impurity of donepezil). Impurity isolation and structure elucidation were discussed.