TY - JOUR T1 - Quantification of Edoxaban Tosylate Monohydrate in Pharmaceutical API And Dosage Form by a Novel UV-Spectrophotmetric Method: Development and Validation AU - Dadi, Vasudha AU - Gandi, Anusha AU - Adari, Jagadeesh AU - Sappa, Manoj Kumar AU - Kollabathula, Varaprasada Rao PY - 2025 DA - December Y2 - 2025 DO - 10.52794/hujpharm.1649224 JF - Hacettepe University Journal of the Faculty of Pharmacy JO - HUJPHARM PB - Hacettepe University WT - DergiPark SN - 2458-8806 SP - 329 EP - 337 VL - 45 IS - 4 LA - en AB - 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. KW - Edoxaban KW - Method development KW - UV Spectrometry KW - Validation CR - 1. Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727-733. https://doi.org/10.1056/NEJMoa2001017 CR - 2. Bathala MS, Masumoto H, Oguma T, He L, Lowrie C, Mendell J. Pharmacokinetics, biotransformation, and mass balance of edoxaban, a selective, direct factor Xa inhibitor, in humans. 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