SavedAdd your journal

Journals / Hacettepe Üniversitesi Eczacılık Fakültesi Dergisi / 2025 / Volume: 45 Issue: 4

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

Vasudha Dadi(Vignan Institute of Pharmaceutical Technology)0000-0003-3862-0590
Anusha Gandi(Vignan Institute of Pharmaceutical Technology)0000-0002-0474-546X
Jagadeesh Adari(GITAM School of Technology)0009-0002-9842-4137
Manoj Kumar Sappa(Vignan Institute of Pharmaceutical Technology)0009-0004-1731-0408
Varaprasada Rao Kollabathula(Vignan Institute of Pharmaceutical Technology)0000-0003-2967-1169
Pages
—
Publication Date
2025-12-01
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

This method is suitable for routine analysis of Edoxaban in bulk form, offering a reliable tool for quality control in pharmaceutical settings.

📌 3 Key Takeaways

🎯
Objective & Hypothesis: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).
📊
Key Findings & Data:Standard and working solutions of Edoxaban tosylate monohydrate were prepared, followed by the preparation of aliquots of working solutions at various concentrations.
💡
Conclusion & Impact:This method is suitable for routine analysis of Edoxaban in bulk form, offering a reliable tool for quality control in pharmaceutical settings.
🔬Design:Research Article
📍Scope:Comprehensive Sample
⚙️Variables:Edoxaban · Method development · UV Spectrometry

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.

🔖

Cite This Article

Dadi, V., Gandi, A., Adari, J., Sappa, M. K., Kollabathula, V. R. (2025). Quantification of Edoxaban Tosylate Monohydrate in Pharmaceutical API And Dosage Form by a Novel UV-Spectrophotmetric Method: Development and Validation. Hacettepe Üniversitesi Eczacılık Fakültesi Dergisi, Volume: 45 Issue: 4. https://doi.org/10.52794/hujpharm.1649224

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (24)

  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
  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. Drug Metab Dispos. 2012;40(12):2250-2255. https://doi.org/10.1124/dmd.112.046888
  3. Gous T, Couchman L, Patel JP, Paradzai C, Arya R, Flanagan RJ. Measurement of the direct oral anticoagulants apixaban, dabigatran, edoxaban, and rivaroxaban in human plasma using turbulent flow liquid chromatography with high-resolutionmass spectrometry. Ther Drug Monit. 2014;36(5):597-605. https://doi.org/10.1097/FTD.0000000000000059
  4. Zhang WL, Lou D, Zhang D, Zhang Y, Huang HJ. Determination of rivaroxaban, apixaban and edoxaban in rat plasma by UPLC–MS/MS method. J Thromb Thrombolysis. 2016;42(2):205-211. https://doi.org/10.1007/s11239-016-1367-y
  5. Karajgi S, Kulkarni RV, Potadar S, Ingale A, Patil S, Chetan M. Quantitative detection of rebamipide by zero-order uv-spectrophotometry using dimethyl formamide solvent system. Res J Pharm Technol. 2024;17(7):3353-3357.https://doi.org/10.52711/0974-360X.2024.00524
  6. Lindahl S, Dyrkorn R, Spigset O, Hegstad S. Quantification of apixaban, dabigatran, edoxaban, and rivaroxaban in human serum by UHPLC-MS/MS: method development, validation, and application. Ther Drug Monit. 2018;40(33):369-376. https://doi.org/10.1097/FTD.0000000000000509
  7. Wiesen MHJ, Blaich C, Streichert T, Michels G, Müller C. Paramagnetic micro-particles as a tool for rapid quantification of apixaban, dabigatran, edoxaban and rivaroxaban in human plasma by UHPLC-MS/MS. Clin Chem Lab Med. 2017;55(9):1349-1359. https://doi.org/10.1515/cclm-2016-0888.
  8. Dhiware TK, Patil PA, Salaraya MG. Development and validation of HPTLC method for determination of edoxaban in bulk and tablet. Asian J Pharm Anal. 2019;9(3):161-166. https://doi.org/10.5958/2231-5675.2019.00029.2
  9. Reddy PS, Jagarlapudi VSK, Sekharan CB. Determination of edoxaban in bulk and in tablet dosage form by stability indicating high-performance liquid chromatography. Pharm Sci. 2016;22(1):35-41. https://doi.org/10.15171/PS.2016.07.
  10. Abdulkadir Kiliç, Mehmet Aslan, Abdulkadir Levent, Investigation of the electrochemical properties of edoxaban using glassy carbon and boron-doped diamond electrodes and development of an eco-friendly and cost effective voltammetric method for its determination,Analytical Biochemistry, Volume 685,2024,115386,ISSN 0003-2697. https://doi.org/10.1016/j.ab.2023.115386.
  11. Kiliç A, Aslan M, Önal G, Levent A. Firstly electrochemical investigetions and determination of anticoagulant drug edoxaban at single-use pencil graphite electrode: an eco-friendly and cost effective voltammetric method. Daru. 2023 Dec;31(2):233-241. doi: 10.1007/s40199-023-00478-8. Epub 2023 Sep 11. https://doi.org/10.1007/s40199-023-00478-8
  12. Ravisankar P. Development and validation of UV spectrophotometric method for the determination of edoxaban tosylate monohydrate in pharmaceutical dosage form. Indian J Res Pharm Biotechnol. 2018;6(2):73-78. https://doi.org/20.62062/02022073-7820Hacettepe
  13. Chourasiya K, Chakraborty AK. Analytical method development and validation for the simultaneous estimation of candesartan and simvastatin by UV-spectrophotometry method. Res J Pharm Technol. 2024;17(7):3151-3155.https://doi.org/10.52711/0974-360X.2024.00492
  14. Lindahl S, Dyrkorn R, Spigset O, Hegstad S. Quantification of apixaban, dabigatran, edoxaban, and rivaroxaban in human serum by UHPLC-MS/MS: method development, validation, and application. Ther Drug Monit. 2018;40(33):369-376. https://doi.org/10.1097/FTD.0000000000000509
  15. Aabid M, Memon S, Pathan D, Hangad T. Development and validation of a UV spectroscopic method to estimate eltrombopag olamine along with bulk and in-house formulation. Res J Pharm Technol. 2023;16(11):5010-5014. https://doi.org/10.52711/0974-360X.2023.00811
  16. Aher KB, Bhavar GB, Shelke MR, Sayyad SF. Environmentally friendly analytical methods for quantitative measurement of sofosbuvir in pharmaceutical formulations: comparison of HPTLC and UV spectrophotometric approaches. Res J Pharm Technol. 2023;16(8):3830-3836.https://doi.org/10.52711/0974-360X.2023.00632
  17. Chauhan NP, Surti N, Patel MP. Analytical method development and validation of methoxy-poly(ethylene glycol)-succinimidyl succinate linker by UV spectroscopy. Res J Pharm Technol. 2023;16(7):3275-3279.https://doi.org/10.52711/0974-360X.2023.00539
  18. Karajgi S, Kulkarni RV, Potadar S, Ingale A, Patil S, Chetan M. Quantitative detection of rebamipide by zero-order UV-spectrophotometry using dimethyl formamide solvent system. Res J Pharm Technol. 2024;17(7):3353-3357.https://doi.org/10.52711/0974-360X.2024.00524
  19. Anusha G, Nargiz S, Sireesha A, Poojitha K, Rao KV, Rao YS. Green solvent-based uv spectrophotometric technique for quantifying molnupiravir in bulk and pharmaceutical formulation. Res J Pharm Technol. 2024;17(11):5210-4. https://doi.org/10.52711/0974-360X.2024.00797.
  20. Panda M, Dadi V, Yarraguntla SR, Rao VP. RP-HPLC method for determination of azelnidipine and telmisartan in pharmaceutical dosage form. Res J Pharm Technol. 2023;16(2):509-13. https://doi.org/10.52711/0974-360X.2023.00086.
  21. Rao K, Prasad V, Vasudha D. Visible Spectrophotometry Methods for The Estimation of Modafinil In Pharmaceutical Formulation. Indian Drugs. 2022 Sep 1;59(9). https://doi.org/10.53879/id.59.09.10283.
  22. Gandi A, Dudi PK, Pantala ES, K VR, Yarguntla SR. A Comprehensive New Approach to Method Development and Validation of Encorafenib using UV Spectroscopy in Bulk and Pharmaceutical Formulation. HUJPHARM. 2024;44(4):318-27. https://doi.org/10.52794/hujpharm.1479058.
  23. Srinivasarao Y, Kumar TH, Chiranjivi P, Rao KV. Simultaneous Estimation of Solifenacin Succinate and Tamsulosin Hydrochloride in Combined Dosage Form by Using First Order Derivative Spectrophotometric Method. Indian Journal of Pharmaceutical Sciences. 2021;83(2).
  24. Lakshmi GT, Rao YS, Rao K, Prasada V, Kumar TH. RP-HPLC method for estimation of atomoxetine hydrochloride in bulk and pharmaceutical dosage form. Research Journal of Pharmaceutical Biological and Chemical Sciences. 2015;6(2):1208-14.