Katuroju Srinivasachary^1,*,, 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

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.

Eltrombopag olamine, 2-Amino phenol, Impurities.