Stability-indicating RP-HPLC method development and validation for Eltrombopag olamine in the presence of impurities and degradation products. Robustness by Design of expert.
Rajeshwari DandabattinaB Subramanian VelusamyKaruna Sree MeruguSharath Babu HaridasyamNaresh Kumar KatariLeela Prasad KowtharapuPublished in: Journal of AOAC International (2022)
The proposed article is the first-ever RP HPLC method for determining impurities in ELO film-coated tablets and drug substances. QbD concept was utilized to verify the method performance.