Stability indicating UHPLC method, development and validation for estimation of eltrombopag and related impurities in tablet dosage form

Abstract

A novel, agile, mass compatible, stability indicating isocratic method developed by using ultra high performance liquid chromatographic (UHPLC) for estimation of Eltrombopag along with its impurities in tablet formulation.Achieved a good separation on Agilent SB C8 (50× 3.0 mm, 1.8 μ) column and mobile phase composed of acetonitrile and 0.1% glacial acetic acid buffer in the ratio of 60:40 v/v at 0.4 ml/minute flow rate and 25 °C column temperature within runtime of 15 minutes. Eltrombopag was detected at 230 nm. The proposed method proves its stability indicating power by resolving Eltrombopag peak from its process impurities and degradation products with more than resolution 2.0. The proposed method is not only simple but capable to separate its potential degradant. The intended method is efficient to determine assay of Eltrombopag in the existence of its impurities within the same run. The retention time observed for Eltrombopag is about 3.9 minutes. The designed method is validated for precision, accuracy, sensitivity, robustness and specificity parameters according to ICH guidelines. Eltrombopag was exposed to stress conditions in acidic, basic, thermal, water, oxidative, humidity and photo degradation. Noticeable degradation is observed in oxidative hydrolysis.