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Abstract

NEW METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ELTROMBOPAG IN BULK AND TABLET DOSAGE FORM BY HPLC

Narottam Pal*, P. Pravalika, D. Sherisha Bhavani, Geetha R., Ayesha Afreen and A. Srinivasa Rao

ABSTRACT

The present analytical work is a unique method development and validation for the determination of Eltrombopag by using reverse phase High performance liquid chromatography (HPLC) with isocratic elution technique. Here the stationary phase used was Xterra C18 (150mm x 4.6mm x 5μm), mobile phase was 40% potassium di-hydrogen phosphate (0.01N) and 60% Acetonitrile. pH of the mobile phase was maintained at 3.0, flow rate 1 ml/minute. Eluted material underwent for monitoring at the detector wavelength of 282 nm. Retention time for Eltrombopag was found to be 2.24 minutes; linearity range was 25 μg/ml to 150 μg/ml. The new method was evaluated according to ICH guideline and as far as validation results are concern correlation coefficient value was 0.998 for the very compound, LOD 0.062 μg/ml, LOQ 0.188 μg/ml, percentage recovery 99.83%, repeatability results relative standard deviation (%RSD) 0.40 for Eltrombopag. The developed HPLC method was found to be a simple and rapid one for regular analysis in professional laboratory.

Keywords: Eltrombopag, HPLC, method development, validation.


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