Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF ELTROMBOPAG OLAMINE IN PHARMACEUTICAL DOSAGE FORM

Mayank Sindhuriya*, Geeta V. Chaudhari, Priyanka Shah and Suleman S. Khoja

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


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