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Isolation, Synthesis and Characterization of Novel Process Related Impurities in Cetirizine Dihydrochloride by Mass and NMR Spectrometry

Authors(8):

Laki P. Magar, Bhaskar H. Zaware, Kishor More, Brajesh Sharma, Kailas Shikhare, Rajesh Kamath, Prashant Patil, Leena Gupta
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Two new process related impurities were observed in Cetirizine dihydrochloride samples when analyzed by United States Pharmacopeia (USP) described high performance liquid chromatography method (HPLC). These impurities were isolated using Preparative high performance liquid chromatography followed by full characterization using analytical techniques like mass, 1H, 13C-NMR and designated as ()-2,2-bis[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid and bis[[1-(4-chlorophenyl)-1-phenyl]methyl]ether. These impurities were also synthesized and reconfirmed by co-injection in HPLC.

Laki P. Magar, Bhaskar H. Zaware, Kishor More, Brajesh Sharma, Kailas Shikhare, Rajesh Kamath, Prashant Patil, Leena Gupta

Cetirizine; Process-related impurities, Identification, Synthesis, HPLC

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Publication Details

Published in : Volume 4 | Issue 3 | January-February - 2018
Date of Publication Print ISSN Online ISSN
2018-01-22 2395-1990 2394-4099
Page(s) Manuscript Number   Publisher
14-18 IJSRSET184305   Technoscience Academy

Cite This Article

Laki P. Magar, Bhaskar H. Zaware, Kishor More, Brajesh Sharma, Kailas Shikhare, Rajesh Kamath, Prashant Patil, Leena Gupta, "Isolation, Synthesis and Characterization of Novel Process Related Impurities in Cetirizine Dihydrochloride by Mass and NMR Spectrometry", International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 4, Issue 3, pp.14-18, January-February-2018.
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