Abstract
An unknown impurity formed during stability sample analysis by a gradient reversed phase ultra-high pressure liquid chromatography (UHPLC) of varenicline tablets at 0.2% level. A simple isocratic preparative method was developed to isolate the unknown impurity with 20 min run time. This unknown impurity was identified and characterized by using spectroscopic techniques. Based on the spectral data, the unknown impurity has been characterized as 4,6,7,8,9,10-hexahydro-1H-6,10-methanopyrazino[2,3-h][3]benzazepine-2,3-dione. The structure of this impurity was also established unambiguously, prepared by isolation and co-injected into UHPLC to confirm the retention time. To the best of our knowledge, this impurity has not been reported elsewhere.
Highlights
Varenicline is a highly selective partial agonist of the nicotinic acetylcholine receptor α4β2 subtype [1]
It is hypothesized that varenicline, a partial agonist, blocks the full-agonist activity of nicotine by competitive binding
The degradation samples were analyzed by ultra-high pressure liquid chromatography (UHPLC) method [7]
Summary
Varenicline is a highly selective partial agonist of the nicotinic acetylcholine receptor α4β2 subtype [1]. This research paper describes the preparative separation, isolation, identification and characterization of an unknown impurity of Varenicline tablets. Identification, Isolation and Characterization of an Unknown Impurity of Varenicline
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