Abstract

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

Dharti Patel*, Miral Patel, Dr. Sumer Singh, Dr. Keyur Ahir

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 Xbridge C18 (150mm x 4.6mm x 5μm), mobile phase was 30% potassium di-hydrogen phosphate and 70% Acetonitrile. pH of the mobile phase was maintained at 3.0, flow rate 1.3 ml/minute. Eluted material underwent for monitoring at the detector wavelength of 230 nm. Retention time for Eltrombopag was found to be 4.6 minutes; linearity range was 12.540 μg/mL to 135.433 μg/mL The new method was evaluated according to ICH guideline and as far as validation results are concern correlation coefficient value was 1.0000 for the compound, Percentage recovery 100.5%, repeatability results relative standard deviation (%RSD) 0.6 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.