Manuscript Number : IJSRSET207452

Spectrophotometric determination of Rivaroxaban in bulk drug and oral dosage formulation

Authors(3) :-Vikramsinh R. Chauhan, Deepshikha Sharma, Kartik B. Vyas

A simple, rapid, cost effective and extractive UV-Vis spectrophotometric method has been developed for the determination of Rivaroxaban (RIV) in bulk drug and pharmaceutical formulation. It was based on UV-Vis spectrophotometric measurements in which the drug made a complex with bromocresol green dye (BCG) in acidic medium and give stable pale yellow colored complex which exhibits absorption maximum at 416 nm. Beer’s law was obeyed in the concentration range of 2 - 40 ?g /ml. This method was tested and validated for various parameters according to ICH guidelines. The proposed method was successfully applied for the determination of RIV in oral formulation. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 2 %). As it is simple, cheap and less time consuming, it can be suitably applied for the estimation of RIV in dosage forms in quality control labs.

Authors and Affiliations

Vikramsinh R. Chauhan
Department of Chemistry, Sheth L.H. Science College, MANSA, India (Scholars of Gujarat University, Ahmedabad)
Deepshikha Sharma
Department of Chemistry, Sheth L.H. Science College, MANSA, India (Scholars of Gujarat University, Ahmedabad)
Kartik B. Vyas
Department of Chemistry, Sheth L.H. Science College, MANSA-382845, Gujarat University, Ahmedabad, India.

UV-spectra, complex, Rivaroxaban, LOQ, LOD, formulation

  1. Mustafa Ç, Tuba R, Engin K, Sacide A. RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms. Brazilian Journal of Pharmaceutical Sciences. 2013; 49: 359-366.
  2. Hetal J, Batuk D, Madhavi P, Yashwantsinh J, Anamik S. Stress study and estimation of a potent anticoagulant drug rivaroxaban by a validated HPLC method: Technology transfer to UPLC. Journal of Chemical and Pharmaceutical Research. 2015; 7:65-74.
  3. Roehrig S, Straub A, Pohlmann J, Lampe T, Pernerstorfer J, Schlemmer KH, Reinemer P, Perzborn E. Discovery of the Novel Antithrombotic Agent 5-Chloro-N-({(5S)-2-oxo-3- 4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939):  An Oral, Direct Factor Xa Inhibitor. J. of medicinal chemistry. 2005; 48: 5900-5908
  4. G Rohde. Determination of rivaroxaban--a novel, oral, direct Factor Xa inhibitor--in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J. of chromatography. B, Analytical technologies in the biomedical and life sciences. 2008; 872: 43-50
  5. IB Lories, AA Mostafa, MA Girges. Use of HPLC in drug analysis. J. of chromatographic separation technique. 2013; 4: 1-6
  6. Kreutz, R.; Pharmacodynamic and pharmacokinetic basics of rivaroxaban; Fundamental and Clinical Pharmacology. 2012; 26: 27-32.
  7. Harenberg J, Kramer R, Christina G, Svetlana M, Christel W. Determination of rivaroxaban by different factor Xa speci?c chromogenic substrate assays: reduction of interassay variability. J Thromb Thrombolysis. 2011; 32: 267-271.
  8. Asmis LM, Alberio L, Angelillo-Scherrer A, Korte W, Mendez A, Rivaroxaban: Quantification by anti-FXa assay and influence on coagulation tests A study in 9 Swiss laboratories. Thromb Res. 2012;129: 492-498.
  9. Mani H, Rohde G, Stratmann G, Hesse C, Herth N, Accurate determination of rivaroxaban levels requires different calibrator sets but not addition of antithrombin. Thromb Haemost. 2012; 108: 191-198.
  10. Samama MM, Contant G, Spiro TE, Perzborn E, Guinet C. Rivaroxaban anti-factor xa chromogenic assay field trial laboratories. Evaluation of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls. Thromb Haemost. 2012; 107: 379-387.
  11. Samama MM, Contant G, Spiro TE, Perzborn E, Flem LL, Rivaroxaban prothrombin time field trial laboratories. Evaluation of the prothrombin time for measuring rivaroxaban plasma concentrations using calibrators and controls: results of a multicenter field trial. ClinApplThromb/Hemost, 2012; 18: 150-158.
  12. Rohde G. Determination of rivaroxaban--a novel, oral, direct Factor Xa inhibitor--in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J ChromatogrB Analyt Technol Biomed Life Sci. 2008; 872: 43-50.
  13. Ramisetti NR, Kuntamukkala R. Development and validation of a stability indicating LC-PDA-MS/MS method for separation, identification and characterization of process related and stress degradation products of rivaroxaban. RSC Adv 2014;4: 23155- 23167.
  14. Reddy GS, Reddy SLNP, Reddy LSK. Development and validation of Hplc-Ms/ Ms method for rivaroxaban quantitation in human plasma using solid phase extraction procedure. Orient J Chem. 2016; 32: 1145-1154.
  15. Darshna V, Pinak P. High performance thin layer chromatographic method with densitometry analysis for determination of rivaroxaban from its tablet dosage form. Int J Pharm Pharm Sc. 2014; 6: 383-386.
  16. Lories IB, Mostafa AA, Girges MA. High performance liquid chromatography, TLC densitometry, First-derivative and First-derivative ratio spectrophotometry for determination of rivaroxaban and its alkaline degradates in bulk powder and its tablets. Chromatogr Sep Tech. 2013; 4: 1-6.
  17. Satyanarayana PVV, Madhavi AS. RP-HPLC method development and validation for the analyisis of rivaroxaban in pharmaceutical dosage forms.Int J Sci Inno Dis. 2012; 2: 226-231.
  18. Chandra sekhar K, Vani PS, Dhana lakshmi A, Devi CHLL, Anupama B, Narendra D. A new method development and validation for analysis of rivaroxaban in formulation by RP HPLC. Res Desk. 2012; 1: 24-33.
  19. Kasad PA. Photolytic-thermal degradation study and method development of rivaroxaban by RP-HPLC. Int J PharmTech Res. 2013; 5: 1254-1263.
  20. Kasad PA, Muralikrishna KS. Method development and acid degradation study of rivaroxaban by RP-HPLC in bulk. Asian J Pharm Anal. 2013; 3: 62-65.
  21. Kasad PA, Muralikrishna KS. Design and validation of dissolution profile of rivaroxaban by using RP-HPLC method in dosage form. Asian J Pharm Anal. 2013; 3: 75-78.
  22. Celebier M, Recber T, Kocak E, Alt?noz S. RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms. Brazilian J Pharm Sci.2013; 49: 359-366
  23. Seshamamba PSV, Veera PV, Sekaran CB. Application of stability indicating HPLC method with UV detector to the analysis of rivaroxaban in bulk and tablet dosage form. Chem Sci Trans.2014;3:1546-1554.
  24. Hetal J, Batuk D, Madhavi P, Yashwantsinha J.Stress study and estimation of a potent anticoagulant drug rivaroxaban by a validated HPLC method: Technology transfer to UPLC. J Chem Pharm Res. 2015; 7: 65-74 .
  25. Maurício EW, Rafaela FP, Francielle SDS, Clóvis DACJ, Iorhann SS. Development and validation of a stability-indicating RP-HPLC method for the determination of rivaroxaban in pharmaceutical formulations. Lat Am J Pharm. 2015; 34: 1503-1510.
  26. Celebier M, Reçber T, Koçak E, Alt?nöz S, K?r S. Determination of rivaroxaban in human plasma by solid-phase extraction-high performance liquid chromatography. J Chromatogr Sci. 2016; 54: 216-220.
  27. Rao PSP, Cholleti VK, Reddy VR.Stability-indicating UPLC method for determining related substances and degradants in rivaroxaban. Int J Res Pharm Sci. 2015; 5: 17-24.
  28. Thurman, E.M., Mills, M.S.; Solid-phase extraction: principles and practice. Wiley, New York, NY, (1998).
  29. Muralikrishna KS, Kasad PA. Spectrophotometric method for determination of rivaroxaban in bulk and tablet formulation and its validation. Inventi Rapid: Pharm Analysis & Quality Assurance 2013: Article ID- “ Inventi:ppaqa/699/13”.
  30. Sekaran CB, Bind VH, Damayanthi MP, Sireesha A. Development and validation of UV spectrophotometric method for the determination of rivaroxaban. Der Pharma Chemica. 2013; 5: 1-5.
  31. Satyanarayana PVV, Madhavi AS. New spectrophotometric methods for the quantitative estimation of rivaroxaban in formulations. Int J Res Rev Pharma Appl Sci. 2012;2: 611-620.
  32. Elbashir AA, Amira ABA. Development and validation of spectrophotometric method for determination of penicillamine (pa) in pharmaceutical formulation using 4-choro-nitrobenzo-2-oxa-1,3-diazol (NBD-CL). World J Anal Chem. 2013; 1: 18-22.
  33. Wahed MGA, El Sheikh R, Gouda AA, Taleb SA. Kinetic spectrophotometric determination of gemifloxacinmesylate and moxifloxacin hydrochloride in pharmaceutical preparations using 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole. J Spectrosc 2014: Article ID 917234, 12 pages.
  34. Ehmann A. The van URK-Salkowski reagent - a sensitive and specific chromogenic reagent for silica gel thin-layer chromatographic detection and identification of indole derivatives. J Chromatogr A. 1997; 132: 267-201.

Publication Details

Published in : Volume 6 | Issue 1 | January-February 2019
Date of Publication : 2019-01-30
License:  This work is licensed under a Creative Commons Attribution 4.0 International License.
Page(s) : 576-584
Manuscript Number : IJSRSET207452
Publisher : Technoscience Academy

Print ISSN : 2395-1990, Online ISSN : 2394-4099

Cite This Article :

Vikramsinh R. Chauhan, Deepshikha Sharma, Kartik B. Vyas, " Spectrophotometric determination of Rivaroxaban in bulk drug and oral dosage formulation , International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 6, Issue 1, pp.576-584, January-February-2019. Available at doi : https://doi.org/10.32628/IJSRSET207452      Journal URL : https://res.ijsrset.com/IJSRSET207452

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