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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Articles in this Issue were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence. Articles are hosted by MDPI on as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
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Sci. Pharm. 2012, 80(2), 329-336;

Identification, Isolation and Characterization of an Unknown Impurity of Varenicline

Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
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
PDF [285 KB, uploaded 29 September 2016]


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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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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