Development and Validation of a Stability-indicating RP-HPLC Method for the Estimation of Eltrombopag in Bulk and Tablet Formulation

Abstract

Aims: A simple, gradient RP- HPLC method has been developed and validated for Eltrombopag in bulk and tablet formulation. Methodology: The method was validated to meet official requirements including selectivity, stability, linearity, precision and accuracy. Successful estimation was carried out for the drug product was developed on C(18) column reversed-phase using acetonitrile: methanol: water in the ratio  (55:35:10 %. v/v)  as mobile phase composition. The flow rate was adjusted to 1ml /minute and the absorption maxima were observed at 230 nm utilizing Shimadzu SPD-20A Prominence UV-Visible detector.  Eltrombopag drug showed a good and precise linearity in the range 2-10 μg/mL. Results: The HPLC, assay showed the purity ranging 99.07 to 100.17% for tablet formulation. The mean percentage purity was 99.76%. The chromatographic retention time of Eltrombopag was found to be 3.10 minutes. The statistical analysis showed the method accuracy. Various forced degradation studies were conducted on Eltrombopag to examine the stability of the drug. The developed method validated as per International Conference on Harmonization (ICH) guidelines. Conclusion: The developed method can be successfully applied for estimation and determination of Eltrombopag in bulk and tablet formulations.