Abstract:
OBJECTIVE To perform the quality control of the bicyclic atypical antidepressant venlafaxine hydrochloride bulk medicine, the venlafaxine hydrochloride photodegradable impurities I2-cyclohexylidene-2-(4-methoxyphenyl)-
N,
Ndimethylethanamine was prepared.
METHODS Through condensation reaction of
p-methoxyphenylacetonitrile and cyclohexanone, LiAlH
4 reduction reaction, formic acid/formaldehyde double methylation reaction, photodegradable impurities I was obtained.
RESULTS The structures of impurities I were confirmed by
1H-NMR,
13C-NMR, MS, and the HPLC indicated that the purity of product was higher than 99.0%.
CONCLUSION The impurities I can be used as impurity reference for quality control of venlafaxine hydrochloride active pharmaceutical ingredient.