Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2021
  • Volume: 14
  • Issue: 6

Development and validation of uplc-ms/ms method for the determination of rivaroxaban in human plasma using liquid-liquid extraction

  • Author:
  • Kailash Chander Malik1, Manoj Karwa2, Gaurav K. Jain3, Rohit Dutt1,*
  • Total Page Count: 5
  • Page Number: 3239 to 3243

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

*Corresponding Author E-mail: rohitdatt23@rediffmail.com

Online published on 25 August, 2021.

Abstract

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.

Keywords

Rivaroxaban, Ultra Performance Liquid Chromatographic, Mass Spectrometric, Human Plasma