Kailash Chander Malik, Manoj Karwa, Gaurav K. Jain, Rohit Dutt
Kailash Chander Malik1, Manoj Karwa2, Gaurav K. Jain3, Rohit Dutt1
1Department of Pharmacy, School of Medical and Allied Sciences, G D Goenka University, Gurugram - 122103, India.
2Auriga Research Private Limited, Plot No. 136, Sector - 5, IMT Manesar, Gurugram.
3Department of Pharmaceutics, Delhi Pharmaceutical Sciences and Research University (DPSRU), Govt. of NCT of Delhi, New Delhi, India.
Volume - 14,
Issue - 6,
Year - 2021
A simple, sensitive, and selective ultra-performance liquid chromatographic (UPLC) method with mass spectrometric (UPLC-MS/MS) detection was developed for the determination of Rivaroxaban in human plasma sample. After a simple protein-precipitation by acetonitrile, the post-treatment samples were separated on a UPLC Bridged Ethyl Hybrid (BEH) C-18 column with 0.2% (v/v) formic acid in water: acetonitrile (60:40, v/v) as a mobile phase and analyzed in positive ion mode. The method developed was validated in human plasma with a daily working range of 2.02–997.72ng/mL with correlation coefficient, r2=0.999936. The method proved to be accurate (recovery, 97.0–107.95%), precise (2.21-7.21%), rapid (run time 2.5 min) and specific. In conclusion, the present validated method could be applied for pharmacokinetic study and bioequivalence testing of Rivaroxaban products.
Cite this article:
Kailash Chander Malik, Manoj Karwa, Gaurav K. Jain, Rohit Dutt. Development and Validation of UPLC-MS/MS Method for the determination of Rivaroxaban in human plasma using Liquid-liquid extraction. Research Journal of Pharmacy and Technology. 2021; 14(6):3239-3. doi: 10.52711/0974-360X.2021.00563
Kailash Chander Malik, Manoj Karwa, Gaurav K. Jain, Rohit Dutt. Development and Validation of UPLC-MS/MS Method for the determination of Rivaroxaban in human plasma using Liquid-liquid extraction. Research Journal of Pharmacy and Technology. 2021; 14(6):3239-3. doi: 10.52711/0974-360X.2021.00563 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-6-53
1. Duggan ST et al. Rivaroxaban a review of its use for the prevention of venous thromboembolism after total hip or knee replacement surgery. Drugs, 2009; 69: 1829-1851.
2. ClinicalTrials.gov. “Oral Direct Factor Xa Inhibitor Rivaroxaban In Patients With Acute Symptomatic Pulmonary Embolism (PE) With Or Without Symptomatic Deep-Vein Thrombosis: Einstein-PE Evaluation”.
3. Perzborn E et al. Rivaroxaban: A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. Hämostaseologie, 2007; 27: 282- 289.
4. Turpie AG et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (Record 4): a randomized trial”. Lancet, 2009; 373: 1673–80.
5. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet, 2008; 47: 285–95.
6. Kasad AP and Muralikrishna KS. Area under curves spectrophotometry method for determination of Rivaroxaban in bulk and tablet formulation and its validation. Asian J. Res. Pharm. Sci. 2013; 3(3): 109-113.
7. Chandrasekhar K et al. A new method development and validation for analysis of rivaroxaban in formulation by RP HPLC. Research Desk. 2012; 1(1): 24-33.
8. Mustafa C et al. HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms. Br. J. Pharm. Sci. 2013; 49(2): 359-366.
9. Kasad AP and Muralikrishna KS. Method Development and Acid Degradation Study of Rivaroxaban by RP-HPLC in bulk. Asian J. Pharm. Ana. 2013; 3(2): 62-65.
10. Shivashankar V et al. Development of validated RP-HPLC method for estimation of rivaroxaban in pharmaceutical formulation. Intl. J. Pharm. Anal. Res. 2015; 4(4): 406-410.
11. Burla S et al. 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(4): 1546-1554.
12. Darshna V and Pinak P. High performance thin layer chromatographic method with densitometry analysis for determination of rivaroxaban from its tablet dosage form. Intl. J. Pharm. Pharma. Sci. 2014;6(6): 383-386.
13. Rohde GJ. Determination of rivaroxaban- a novel, oral, direct factor Xa inhibitor in human plasma by high performance liquid chromatography- tandem mass spectrometry. J. Chromatogr. B. 2008; 872: 43-50.
14. Bajaj S et al. Stability testing of pharmaceutical products. J Appl Pharm Sci. 2012; 2(3).
15. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodology, Q2 (R1), 2005