ISSN : 2663-2187

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION AND FORCED DEGRADATION STABILITY-INDICATING STUDIES OF ELTROMBOPAG OLAMINE BY RP-HPLC AND UV IN BULK AND PHARMACEUTICAL DOSAGE FORM

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Mr. Mohammed Aabid*, Dr. Bakshi AR, Dr. Umair Ahmed, Dr. Taarique Deshmukh, Dr. Rashid Akhtar
» doi: 10.33472/AFJBS.6.5.2024. 3816-3832

Abstract

In this proposed investigation, the aim was to develop and validate a rapid and accurate HPLC and UV spectrophotometric method for quantifying Eltrombopag Olamine in bulk and tablet formulations. The objectives involved creating an environmentally friendly method for assessing the substance using RP-HPLC and UV analysis, including forced degradation studies. Ethanol served as the optimal solvent, with an absorption wavelength of 423 nm, exhibiting linear response within a concentration range of 5-30 μg/ml and a regression coefficient of 0.996. The method underwent rigorous validation according to ICH criteria, demonstrating acceptable results. Overall, this novel and precise method was found to be suitable for Eltrombopag Olamine estimation in bulk and pharmaceutical formulations, utilizing an inertsil ODS-3V C18 150mm x 4.6mm x 5μ column with a mobile phase of buffer pH 3.5 and acetonitrile (90:10) at a flow rate of 1.0 ml/min, and detection at 280 nm via PDA.

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