Key result
A highly selective and sensitive LC-MS/MS method was developed and validated for the estimation of Rivaroxaban in human plasma, demonstrating a linear concentration range of 1.00-603.25 ng/mL.
A highly sensitive and efficient LC-MS/MS method was successfully developed and validated for quantifying rivaroxaban in human plasma.
Validated LC-MS/MS assay aids rivaroxaban research; leaves open clinical TDM adoption pending patient studies.
A highly selective, sensitive, and reproducible liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated for the determination of Rivaroxaban in human plasma using Rivaroxaban D4 as internal standard (IS). Liquid-liquid extraction technique using extraction solvent was used for extraction of analyte and IS. Rivaroxaban and IS were analyzed on Thermo BDS Hypersil C-18 (150 mm × 4.6 mm, 5 μm) column using acetonitrile and 10 mM ammonium acetate buffer in a ratio 80:20 v/v. Mass Detection and quantitation were performed under multiple reaction monitoring using ESI for Rivaroxaban (m/z 436.1 → 145.0) and Rivaroxaban D4 (m/z 440.2 → 144.9), respectively. The advantage of the method includes higher sensitivity (1.00 ng/mL), superior extraction efficiency (>90 %), and small sample volume (200 μL) for processing. The method was linear in the concentration range of 1.00-603.25 ng/mL and method validation was performed as per USFDA guidelines and the results were within the acceptance criteria.
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Pathan et al. (2020) studied this question. LC-MS/MS method for Rivaroxaban estimation was evaluated on Method validation for Rivaroxaban determination. A highly selective and sensitive LC-MS/MS method was developed and validated for the estimation of Rivaroxaban in human plasma, demonstrating a linear concentration range of 1.00-603.25 ng/mL.
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