Synthesis and Characterization of Potential Impurities of Eltrombopag Olamine

Katuroju Srinivasachary1,*,, Chennuri Rajesh1, Shashikant Tiwari1, Y.S. Somannavar1, Sailendra Kumar Nadakudity1, Krishna Murthy V.R. Moturu1, Samala Bhanuchadar1 and Bhoomireddy Ramadevi2

1Chemical Research and Development, APL Research Centre-II, Aurobindo Pharma Ltd., Survey No.71 & 72, Indrakaran Village, Kandi Mandal, Sangareddy District-502329, India

2Department of Chemistry, Jawaharlal Nehru Technological University Hyderabad, Hyderabad-500072, India

*Corresponding author: E-mail: kathrojusrinivasachary@gmail.com

Abstract

This work reports the feasibility of recently developed industrial viable process for eltrombopag olamine starting from 2-bromo-6-nitro phenol and reports the identification of four potential impurities related to eltrombopag olamine, namely eltrombopag olamine ester (1), 2-aminophenol analogue of eltrombopag (2), 3,3′-(2-amino-3-oxo-3H-phenoxazine-4,6-diyl dibenzoic acid (3), 2′-hydroxy[1,1-biphenyl]-3-carboxylic acid (4). These impurities are the crucial components in determining the quality of the drug substance, eltrombopag olamine during its manufacturing. These impurities have impact on the quality of eltrombopag olamine and controlled these impurities results excellent yields of active pharma ingredient of eltrombopag olamine.

Keywords

Eltrombopag olamine, 2-Amino phenol, Impurities.

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