title: A validated high-throughput UHPLC-MS/MS assay for accurate determination of rivaroxaban in plasma sample.
abstract: Rivaroxaban is a novel, selective and potent oral direct factor Xa inhibitor, therapeutically indicated in the treatment of thromboembolic diseases. Like traditional anticoagulants, routine coagulation monitoring of rivaroxaban is not necessary, but important in some clinical circumstances. In this study, a sensitive UHPLC-MS/MS assay for rapid determination of rivaroxaban in human plasma was developed and validated. Rivaroxaban and its internal standard (IS) were extracted from plasma using acetonitrile as protein precipitating agent. An isocratic mobile phase of acetonitrile: 10 mM ammonium acetate (80:20, v/v) at a flow rate of 0.3 mL/min was used for the separation of rivaroxaban and IS. Both rivaroxaban and IS was eluted within 1 min with a total run time of 1.5 min only. Electrospray ionization source in positive mode was used for the detections of rivaroxaban and IS. Precursor to product ion transition of m/z 436.00 > 144.87 for rivaroxaban and m/z 411.18 > 191.07 for IS were used in multiple reaction monitoring mode. Developed assay was fully validated in terms of selectivity, linearity, accuracy, precision, recovery, matrix effects and stability using official guideline on bioanalytical method.
authors.affiliation: Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, PO BOX 2457, Riyadh, 11451, Saudi Arabia, muziqbal@gmail.com.
authors.forename: Muzaffar
authors.initials: M
authors.lastname: Iqbal
authors.forename: Nasr Y
authors.initials: NY
authors.lastname: Khalil
authors.forename: Faisal
authors.initials: F
authors.lastname: Imam
authors.forename: Md
authors.initials: M
authors.lastname: Khalid Anwer
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D065427:Factor Xa Inhibitors / Q000032:analysis / Q000493:pharmacokinetics; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods; D009025:Morpholines / Q000032:analysis / Q000493:pharmacokinetics; D010949:Plasma; D000069552:Rivaroxaban; D013876:Thiophenes / Q000032:analysis / Q000493:pharmacokinetics
chemical_list: D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban
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