UPLC METHOD DEVELOPMENT AND VALIDATION FOR EDOXABAN ESTIMATION IN BULK AND PHARMACEUTICAL DOSAGE FORM

Dr. Narasimha Rao B. V.*, Dr. Prasada Rao M., Udaya Krishna Veni A., Rushitha K., Haripriya Bai M., Pathan Bhibi Fathima, Chitti Ishwarya U., Rakibul Dewan

In order to estimate Edoxaban in bulk and pharmaceutical formulations, this work designed and validated a reverse phase ultra-performance liquid chromatography method. Several technique elements, including mobile phase ratio and column type, were altered in statistically structured studies to evaluate the impact of these variables on the chromatographic separation of Edoxaban. Using ACN: Phosphate buffer (pH 3.0) (70:30), the separation was performed at ambient temperature under isocratic conditions at a flow rate of 0.2 mL/min on a BEH C18 (2.1 x 50mm, 1.7μm) Column and 5μm. The maximum absorbance 298 nm was measured by a PDA detector. The retention time was found to be 1.520mins whereas run time was 3mins only. In between the concentration range of 15-90 μg/mL, the calibration curve was linear. The new technique's sensitivity is demonstrated by the calculated LOQ of 0.45μg/mL and the measured LOD of 0.15μg/mL. The approach's robustness and ruggedness were confirmed by the %RSD being less than 2. For formulation analysis, the test percentage was 100.02. As a result, this technique was widely employed to analyse Edoxaban in bulk and pharmaceutical formulations.