Next Article in Journal
Liposomes for Topical Use: A Physico-Chemical Comparison of Vesicles Prepared from Egg or Soy Lecithin
Previous Article in Journal
Ascorbic Acid for the Safe Use of a Sunscreen Agent: Accumulation of Nano Zinc Oxide and Titanium Dioxide on the Skin
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
Sci. Pharm.
Volume 80
Issue 2
10.3797/scipharm.1201-08
scipharm-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles thumb_up
...
Endorse textsms
...
Comment
Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Article

Identification, Isolation and Characterization of an Unknown Impurity of Varenicline

by
Balasubramanian SATHEESH
1,2,*,
Kondayampettai K. SREE GANESH
1 and
Dhandayutham SARAVANAN
2
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.
Sci. Pharm. 2012, 80(2), 329-336; https://doi.org/10.3797/scipharm.1201-08
Submission received: 15 January 2012 / Accepted: 20 March 2012 / Published: 20 March 2012
Versions Notes

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

Share and Cite

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. https://doi.org/10.3797/scipharm.1201-08

AMA Style

SATHEESH B, SREE GANESH KK, SARAVANAN D. Identification, Isolation and Characterization of an Unknown Impurity of Varenicline. Scientia Pharmaceutica. 2012; 80(2):329-336. https://doi.org/10.3797/scipharm.1201-08

Chicago/Turabian Style

SATHEESH, Balasubramanian, Kondayampettai K. SREE GANESH, and Dhandayutham SARAVANAN. 2012. "Identification, Isolation and Characterization of an Unknown Impurity of Varenicline" Scientia Pharmaceutica 80, no. 2: 329-336. https://doi.org/10.3797/scipharm.1201-08

APA Style

SATHEESH, B., SREE GANESH, K. K., & SARAVANAN, D. (2012). Identification, Isolation and Characterization of an Unknown Impurity of Varenicline. Scientia Pharmaceutica, 80(2), 329-336. https://doi.org/10.3797/scipharm.1201-08

Article Metrics

Back to TopTop