Time and Solvent-Saving RP-HPLC Method for Eltrombopag Olamine : Development, Validation, and Stability-Indicating Studies in API and Tablets

Abstract

Background: Eltrombopag olamine is a thrombopoietin receptor agonist widely used in the management of platelet-related disorders, necessitating a reliable analytical method for routine quality control and stability assessment. Methods: An RP-HPLC method with reduced run time and solvent usage was established and validated for the quantitative determination of eltrombopag olamine in active pharmaceutical ingredient and tablet dosage forms. Method validation was carried out in accordance with ICH Q2(R1), and forced degradation studies were conducted following ICH Q1A(R2) recommendations. Results: Chromatographic separation was achieved on an Inert Sustain C18 column (4.6 × 250 mm, 5 µm) using a methanol–acetonitrile mobile phase (90:10, v/v). Detection was performed at 230 nm using a PDA detector. The analyte eluted at approximately 4.3 minutes. The method demonstrated linearity over the concentration range of 5–100 µg/mL with a correlation coefficient of 0.9936. The limits of detection and quantification confirmed adequate sensitivity. Stress degradation studies indicated effective separation of eltrombopag olamine from its degradation products. Conclusion: The validated RP-HPLC method is rapid, economical, and stability-indicating, making it suitable for routine quality control and stability testing of eltrombopag olamine in pharmaceutical formulations.