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

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.

Authors and Affiliations

Laki P. Magar
Department of chemistry, New Arts, Commerce and Science college, Ahmednagar, Maharashtra ,India
Bhaskar H. Zaware
IPCA Laboratories Ltd. Chemical Research Division, Kandivali Industrial Estate,Kandivali (West). Mumbai, Maharashtra, India
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 : 2018-01-22
License:  This work is licensed under a Creative Commons Attribution 4.0 International License.
Page(s) : 14-18
Manuscript Number : IJSRSET184305
Publisher : Technoscience Academy

Print ISSN : 2395-1990, Online ISSN : 2394-4099

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
URL : http://ijsrset.com/IJSRSET184305

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