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Sci. Pharm. 2012, 80(2), 329-336; doi:10.3797/scipharm.1201-08

Identification, Isolation and Characterization of an Unknown Impurity of Varenicline

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
Department of chemistry, National College, Trichy-620 001, India
*
Author to whom correspondence should be addressed.
Received: 15 January 2012 / Accepted: 20 March 2012 / Published: 20 March 2012
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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.
Keywords: Varenicline; Degradant impurity; Preparative HPLC; Isolation; Characterization Varenicline; Degradant impurity; Preparative HPLC; Isolation; Characterization
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

SATHEESH, B.; SREE GANESH, K.K.; SARAVANAN, D. Identification, Isolation and Characterization of an Unknown Impurity of Varenicline. Sci. Pharm. 2012, 80, 329-336.

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