Abstract

QUANTITATIVE ESTIMATION OF EDOXABAN BY ZERO AND FIRST ORDER AREA UNDER CURVE SPECTROPHOTOMETRIC METHOD IN BULK AND IN-HOUSE TABLETS

Tarkeshwari K. Dhiware*, Paresh A. Patil and Mahesh G. Salaraya

Abstract

Aim: The aim of this work is to establish two simple, economical, and rapid spectrophotometric methods for the quantification of Edoxaban in bulk material and in tablets. Further, this study is designed to validate the developed methods as perICH guidelines. Materials and Methods: In Methods I and II, a stock standard solution was prepared by dissolving 10 mg of Edoxaban in 100 mL of 10% v/v Methanol to obtain a concentration of 100 μg/mL. After suitable dilution, 10 μg/mL of Edoxaban was prepared and scanned in the UV-visible range 400– 200 nm; Edoxaban showed a maximum wavelength at 290 nm. In Method I, area under curve (AUC) of the zero-order spectrum was recorded between 283.00 and 300.00 nm. While, in Method II, zero-order spectra were derivatized into first-order, and the AUC was recorded between 299.00 and 314.00 nm. For a linearity study, series of dilutions were prepared from stock solutions. Results: In Method I, and II, Edoxaban followed linearity in the concentration range of 4-24 μg/mL with (r2>0.999). Conclusion: The developed methods are simple, precise, rugged, robust, and economical. Both these methods can be used for routine analysis of Edoxaban from its tablet formulation.

Keywords: Edoxaban, UV Spectrophotometer, Derivative, AUC, Validation.