Quantification of Edoxaban Tosylate Monohydrate in Pharmaceutical API And Dosage Form by a Novel UV-Spectrophotmetric Method: Development and Validation

Year 2025, Volume: 45 Issue: 4, 329 - 337, 01.12.2025

Vasudha Dadi , Anusha Gandi , Jagadeesh Adari , Manoj Kumar Sappa , Varaprasada Rao Kollabathula

https://doi.org/10.52794/hujpharm.1649224

Abstract

The major purpose of this analysis is to develop and validate easy, economic UV-spectrophotometric method useful in the quantification of Edoxaban tosylate monohydrate in active pharmaceutical ingredients (APIs). Standard and working solutions of Edoxaban tosylate monohydrate were prepared, followed by the preparation of aliquots of working solutions at various concentrations. The method was validated by assessing key parameters, including linearity, precision, accuracy, robustness, ruggedness, and the limits of detection and quantitation. The demonstrated method has excellent linearity for Edoxaban in the concentration range of 2-24 μg/mL, with a coefficient of determination (R²) was 0.9998. This method is suitable for routine analysis of Edoxaban in bulk form, offering a reliable tool for quality control in pharmaceutical settings.

Keywords

Edoxaban , Method development , UV Spectrometry , Validation

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