Development And Validation of Reverse Phase High Performance Liquid Chromatography Method for Quantitative Estimation of Edoxaban Using PDA Detector

Abstract

Introduction: Edoxaban is an orally active, highly selective, direct reversible inhibitor of the serine protease factor Xa, and by increasing clotting reduces the risk of thrombus formation. The aim of the present study was to develop a simple, sensitive and accurate liquid chromatographic method for the quantification of Edoxaban.

Material and Methods: Quantification of analyte was achieved by utilizing Shimadzu shim-pack C₁₈(250 mm × 4.6 mm, 5μm) column on Shimadzu (UFLC) liquid chromatography system equipped with LC-20 AD solvent delivery system, SPD-20A photo diode array detector and 20 µl loop volume in a Rheodyne injector. The mobile phase composition was acetonitrile: water in the ratio of (50:50 % v/v) with a flow rate of 1ml/min. Detection was achieved using photo diode array set at 291nm.

Results: Retention time of Edoxaban was found 5.514 min with a total run time of 8 min. The calibration curve was found to be linear over the concentration range of 8-80µg/ml. The LOD and LOQ were found to be 0.283 µg/ml and 0.942 µg/ml, respectively.

Conclusion: The developed method was validated and the results of validation were within the prescribed limits as per International Conference on Harmonisation (ICH) guidelines.