Volume : 12, Issue : 08, August- 2025

Title:

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR THE ESTIMATION OF RIVAROXABAN IN BULK AND TABLET DOSAGE FORM

Authors :

Vaishali K *, Sowmya H.G , Naveen Kumar G.S

Abstract :

The quantification of rivaroxaban in pharmaceutical dosage forms and bulk medication has been accomplished through the development and validation of a new, precise, and effective Area under curve derivative UV spectroscopic approach. The absorbance of rivaroxaban reaches its maximum at 277 nm in 0.1N Hcl, and the Area under curve in absorption spectra measured between wavelength range in 272nm and 282nm , its concentration falls between 2 and 12 µg/mL according to Beer’s Law. A correlation value (R2) of 0.9993 demonstrated the method’s great linearity, demonstrating high consistency and dependability throughout the spectrum under study. While the limits of detection (LOD) and quantitation (LOQ) were determined to be 0.0331 µg/mL and 0.1003µg/mL, respectively, recovery rates ranged from 98.84% to 100.95%. Additionally, the method’s relative standard deviation (%RSD) values were less than 2%, indicating exceptional accuracy. The ICH recommendations were followed in evaluating the following validation parameters: linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ. For regular analysis of rivaroxaban in different pharmaceutical formulations, this verified spectroscopic methodology proved to be a reliable and repeatable method.
Keywords: Rivaroxaban , Area under curve [AUC], Validation , Pharmaceutical formulations.

Cite This Article:

Please cite this article in press Vaishali K et al., Development And Validation Of Uv Spectroscopic Method For The Estimation Of Rivaroxaban In Bulk And Tablet Dosage Form., Indo Am. J. P. Sci, 2025; 12(08).

Number of Downloads : 10

References:

1. Sayeda Z N, Hangad T. Development And Validation of Stability Indicating Assay Method For Rivaroxaban Drug By Hplc.World J Of Pharm Res.2022 may;11(7):1013-1027.
2. Sekaran C B, Bind V H, Damayanthi M R, Sireesha A. Development and validation of UV spectrophotometric method for the determination of rivaroxaban. Der Pharma Chemic. 2013;5(4):1-5.
3. Mueck W, Stampfuss J, Kubitza D, Becka M. Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clinical pharmacokinetics. 2014 Jan;53:1-6.
4. Kvasnicka T, Malikova I, Zenahlikova Z, Kettnerova K, Brzezkova R, Zima T, Ulrych J, Briza J, Netuka I, Kvasnicka J. Rivaroxaban-metabolism, pharmacologic properties and drug interactions. Current drug metabolism. 2017 Jul 1;18(7):636-42.
5. Seshamamba BS, Sekaran CB. Spectrophotometric analysis for the quantification of rivaroxaban in bulk and tablet dosage form. Int J Pharm Pharm Sci. 2017;10.
6. Sahithi K, Kumar PR, Padmavathi Y, Babu NR, Reddy DS, Sravani GJ, Spandana C. Development and validation of bio-analytical method for the quantitative estimation of rivaroxaban by using UV spectrophotometry. World Journal of pharmaceutical sciences. 2020 Feb 1:38-43.
7. Bhavyasri K, Dhanalakshmi C, Sumakanth M. Development and validation of ultra violet-visible spectrophotometric method for estimation of Rivaroxaban in spiked human plasma. Journal of Pharmaceutical Sciences and Research. 2020 Sep 1;12(9):1215-9.
8. Sharaf ED, Ibrahim F, Shalan SH, Abd El-Aziz H. Spectrophotometric methods for simultaneous determination of rivaroxaban and clopidogrel in their binary mixture. Pharm Anal Acta. 2018;9(575):200-80.
9. Çelebier M, Reçber T, Koçak E, Altınöz S, Kır S. Determination of rivaroxaban in human plasma by solid-phase extraction–high performance liquid chromatography. Journal of chromatographic science. 2016 Feb 1;54(2):216-20.
10. Souri E, Mottaghi S, Zargarpoor M, Ahmadkhaniha R, Jalalizadeh H. Development of a stability-indicating HPLC method and a dissolution test for rivaroxaban dosage forms. Acta chromatographica. 2016 Sep;28(3):347-61.
11. Sahoo S, Mekap SK. Assay comparison of rivaroxaban by new HPLC method with an existing method in tablet dosage form. Pharm. Biol. Eval. 2017;4:180-2.
12. Arous B, Al-Mardini MA, Karabet F, Daghestani M, Al-Lahham F, Al-Askar A. Development and validation of a liquid chromatography method for the analysis of rivaroxaban and determination of its production related impurities. Pharmaceutical Chemistry Journal. 2018 Aug;52:483-90.
13. Ismail RA, Ayad MF, Hussein LA, Trabik YA. A bioanalytically validated RP-HPLC method for simultaneous quantification of rivaroxaban, paracetamol, and ceftriaxone in human plasma: a combination used for COVID-19 management. Scientific Reports. 2024 Oct 28;14(1):25693.
14. Rohde G. Determination of rivaroxaban–a novel, oral, direct Factor Xa inhibitor–in human plasma by high-performance liquid chromatography–tandem mass spectrometry. Journal of Chromatography B. 2008 Sep 1;872(1-2):43-50.
15. Derogis PB, Sanches LR, de Aranda VF, Colombini MP, Mangueira CL, Katz M, Faulhaber AC, Mendes CE, Ferreira CE, França CN, Guerra JC. Determination of rivaroxaban in patient’s plasma samples by anti-Xa chromogenic test associated to High Performance Liquid Chromatography tandem Mass Spectrometry (HPLC-MS/MS). PLoS One. 2017 Feb 7;12(2):e0171272.
16. Rohde G. Determination of rivaroxaban–a novel, oral, direct Factor Xa inhibitor–in human plasma by high-performance liquid chromatography–tandem mass spectrometry. Journal of Chromatography B. 2008 Sep 1;872(1-2):43-50.
17. Reçber T, Haznedaroğlu İC, Çelebier M. Review on characteristics and analytical methods of rivaroxaban. Critical Reviews in Analytical Chemistry. 2022 May 19;52(4):865-77.
18. Reddy GS, Reddy SL, Reddy LS. Development and validation of Hplc-Ms/Ms Method for Rivaroxaban quantitation in human plasma using solid phase extraction procedure. Oriental Journal of Chemistry. 2016 Apr 1;32(2):1145-54.
19. Brückner L, Beyer-Westendorf J, Tiebel O, Pietsch J. Development and validation of an analytical method for the determination of direct oral anticoagulants (DOAC) and the direct thrombin-inhibitor argatroban by HPLC–MS/MS. Journal of Thrombosis and Thrombolysis. 2022 May;53(4):777-87.
20. Bhatkar T, Burakle P, Ajmire P, Jawarkar R, Khatale P, Taywade E. RP-HPLC Method Development and Validation of Rivaroxaban in Pharmaceutical Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2024 Jun 1;17(6):2869-74.
21. More JV, Borse SL, Borse LB, Jadhav AG. Review on Reversed-phase High-performance Liquid Chromatography Method Development and Validation for Estimation of Rivaroxaban. Miss. J. and Borse, SL and Borse, LB and Jadhav, AG, Review on Reversed-phase High-performance Liquid Chromatography Method Development and Validation for Estimation of Rivaroxaban (June 15, 2019). International Journal of Pharmaceutical & Biological Archive. 2019;10(2):65-8.
22. Çelebier M, Reçber T, Koçak E, Altınöz S, Kır S. Determination of rivaroxaban in human plasma by solid-phase extraction–high performance liquid chromatography. Journal of chromatographic science. 2016 Feb 1;54(2):216-20.
23. Shukla AH, Shah PJ, Dedhiya PP, Vyas BA, Shah SA. Development and validation of a HPTLC method for rivaroxaban in human plasma for a pharmacokinetic study. Indian J Pharm Sci. 2020 Mar 1;82(2):315-20.
24. Nimje H, Magar M, Kamble P, Rongali N. Validated Stability Indicating HPTLC Method Development for Rivaroxaban in Tablets. Indian Journal of Pharmaceutical Education and Research. 2024 Jun 21;58(3):918-24.
25. Alam P, Ezzeldin E, Iqbal M, Anwer MK, Mostafa GA, Alqarni MH, Foudah AI, Shakeel F. Ecofriendly densitometric RP-HPTLC method for determination of rivaroxaban in nanoparticle formulations using green solvents. RSC advances. 2020;10(4):2133-40.
26. ICHQ2A Text on validation of analytical procedures,https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
27. ICH Q2 (R1) Validation of analytical procedure: Text and methodology, 2005.https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.
28. ICH Q2B: Guidance for Industry: Validation of Analytical Procedures: Methodology U.S Department of Health and Human Services Food and Drug Administration, (CBER),1996