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Vol. 28 No. 4 (2016): Vol 28 Issue 4

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A Sensitive and Selective GC-MS Analysis of Process Related Genotoxic Impurities of Nebivolol Hydrochloride

https://doi.org/10.14233/ajchem.2016.19525
Vijaya Lakshmi Maddala
Inogent Laboratories Private Limited, Plot No. 28 A, Street No. 15, IDA Nacharam, Hyderabad-500 076, India
P.C. Ray
Inogent Laboratories Private Limited, Plot No. 28 A, Street No. 15, IDA Nacharam, Hyderabad-500 076, India
K. Venugopal
Inogent Laboratories Private Limited, Plot No. 28 A, Street No. 15, IDA Nacharam, Hyderabad-500 076, India
K.M.V.N. Rao
Inogent Laboratories Private Limited, Plot No. 28 A, Street No. 15, IDA Nacharam, Hyderabad-500 076, India

Corresponding Author(s) : Vijaya Lakshmi Maddala

vijaya_chem@yahoo.com

Asian Journal of Chemistry, Vol. 28 No. 4 (2016): Vol 28 Issue 4

Abstract

A sensitive GC-MS method has been developed and validated for the estimation of genotoxic impurities namely 2-chloro-1-(6-fluorochroman 2-yl)ethanone (1), 2-chloro-1-(6-fluorochroman 2-yl)ethanol (2) and 6-fluoro2-(oxiran2-yl)chroman (3) in nebivolol hydrochloride drug substance. Under optimized conditions of the proposed method is specific, precise, linear, accurate and rugged. The response was linear in the concentration range of limit of quantification to 0.07 mg g-1 with correlation coefficients of > 0.99 for each impurity. Under optimum conditions used for the sample preparation the recovery of each impurity is in between 70-130 %.

Keywords

Genotoxic impurities Nebivolol GC-MS
Maddala, V. L., Ray, P., Venugopal, K., & Rao, K. (2015). A Sensitive and Selective GC-MS Analysis of Process Related Genotoxic Impurities of Nebivolol Hydrochloride. Asian Journal of Chemistry, 28(4), 811–813. https://doi.org/10.14233/ajchem.2016.19525
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