Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ELTROMBOPAG OLAMINE BY RP- HPLC METHOD

Ahesar Tamboli*, Prof. Shakeel Memon and Prof. Tabassum Hangad

ABSTRACT

A reversed-phase liquid chromatographic method has been developed and validated for estimation of Eltrombopag Olamine in Pharmaceutical Dosage Form. RP-HPLC method, Column used was 150 x 4.6mm 5μ C18, Hypersil BDS with mobile phase containing 10mM Potassium dihydrogen Phosphate + 1% TEA (pH 4.5 Adjusted using Ortho phosphoric acid): Acetonitrile (50:50). The flow rate (1.0 ml/min) and wavelength (226 nm). The retention time of Eltrombopag Olamine was found to be 4.509 min, respectively. Correlation co-efficient for Eltrombopag Olamine was found to be 0.999. Assay result of marketed formulation was found to be in 99.7% for Eltrombopag Olamine. The proposed method was validated with respect to linearity, accuracy, precision and robustness. Percentage recovery for Eltrombopag Olamine was found to be 99.7 – 100.0%. Analysis proves that the developed method was successfully applied for the analysis of pharmaceutical formulations and can be used for routine analysis of drugs in Quality Control laboratories.

Keywords: Analytical method development, validation, Eltrombopag Olamine, HPLC, ICH guidelines.