DEVELOPMENT AND VALIDATION OF STABILTY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ELTROMBOPAG AND ROMIPLOSTIM IN BULK AND TABLET DOSAGE FORM

A simple, economical, sensitive and reproducible stability indicating RP-HPLC method for the simultaneous estimation of Eltrombopag and Romiplostim in bulk and tablet dosage form has been developed and validated. Chromatographic isocratic separation was carried out on Symmetry ODS C18 (4.6 x 150 mm, 5 mu particle size) column using a mobile phase composed of phosphate buffer: acetonitrile (adjusted to pH 2.5 with 0.1 % OPA) in the ratio of 20: 80 % v/v at a flow rate of 0.8 ml/min. The analyte was monitored using UV detector wavelength at 274 nm at ambient column temperature. The retention time was found to be 2.003 min and 5.067 min for Eltrombopag and Romiplostim respectively. The proposed method was found to be linear in the concentration range of 10-50 mu g/ml for Eltrombopag and 25-125 mu g/ml for Romiplostim with correlation coefficient value of 0.999 respectively. The mean % recoveries obtained were found to be 99.6-99.7% for Eltrombopag and 99.7-99.8% for Romiplostim respectively. Stress testing which covered acid, alkali, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The developed method has been statistically validated according to ICH guide lines and found to be linear, precise, accurate and robust. The proposed method can be successfully applied for the stability indicating RP-HPLC simultaneous estimation of Eltrombopag and Romiplostim in bulk and tablet dosage form and in routine quality control analysis.