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Quantification of 4-Oxiranyl Methoxy-9h-Carbazole a Genotoxic Impurity in Carvedilol Drug Substances by Lc-Ms
M. Srinivasa Rao1*, Sumathi V. Rao1, U.K.Ray1, G.Sri Siva Kumar1, Hemant Kumar Sharma1 and K.Mukkanti2
1Department of Analytical research, Aurobindo Pharma Research Centre, 313 Bachupally, Qutubullapur Mandal, Hyderabad - 500090, India
2Head of Centre for Pharmaceutical sciences, JNTU Institute of sciences & Technology, Kukatpally, Hyderabad - 500085, India
*Corresponding author: APL Research Centre
(A Division of Aurobindo Pharma Ltd.)
313, Bachupally, Quthubullapur
Hyderabad 500090, India
Tel: +91 40 23040261
Fax: +91 40 23042932
E-mail: metta_cnu@yahoo.co.in
 
Received July 02, 2010; Accepted August 23, 2010; Published August 23, 2010
Citation: Srinivasa Rao M, Rao SV, Ray UK, Siva Kumar GS, Sharma HK, et al. (2010) Quantification of 4-Oxiranyl Methoxy-9h-Carbazole a Genotoxic Impurity in Carvedilol Drug Substances by Lc-Ms. J Bioanal Biomed 2: 091-095. doi:10.4172/1948-593X.1000029
 
Copyright: © 2010 Srinivasa Rao M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
 
Abstract
LC-MS multiple reaction monitoring (MRM) method had been evaluated for the determination of the very low level of 4-Oxiranylmethoxy-9H-Carbazole in drug substances such as Carvedilol (U.S. Pharmacopoeia (USP), 32NF-27,British pharmacopoeia (BP), 2009, Martindale 35th edition) This 4-Oxiranylmethoxy-9H-Carbazole have been identified as potential genotoxic impurity. LC-MS was found to be more promising and the limit of quantification was 15 µg/gm.
 
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