title: Validation of an LC-MS/MS method for the simultaneous quantification of dabigatran, rivaroxaban and apixaban in human plasma.
abstract: OBJECTIVE
  Novel oral anticoagulants are characterized by a wide therapeutic window, yet the determination of their plasma-drug concentrations may be useful in some clinical conditions.
  
  
  RESULTS
  An LC-MS/MS method for the analysis of dabigatran, apixaban and rivaroxaban in human plasma has been successfully developed and validated. The analysis of plasma samples from patients given other concomitant drugs revealed no significant interference. By reanalysis of samples from patients on anticoagulant therapy, we found the percentage difference in results between the concentration of repeat and the original sample to be within the threshold limit of 20% in 60 of 63 specimens.
  
  
  CONCLUSIONS
  The developed LC-MS/MS assay is easily applicable in the clinical management of patients on anticoagulation therapy.
authors.affiliation: Unit of Clinical Pharmacology, L. Sacco University Hospital, Milano, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Baldelli
authors.affiliation: Unit of Clinical Pharmacology, L. Sacco University Hospital, Milano, Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Cattaneo
authors.affiliation: Department of Internal Medicine & Medical Specialities, Sapienza University of Rome, Roma, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Pignatelli
authors.affiliation: Unit of Clinical Pharmacology, L. Sacco University Hospital, Milano, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Perrone
authors.affiliation: Department of Internal Medicine & Medical Specialities, Sapienza University of Rome, Roma, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Pastori
authors.affiliation: Unit of Clinical Pharmacology, L. Sacco University Hospital, Milano, Italy.
authors.forename: Sonia
authors.initials: S
authors.lastname: Radice
authors.affiliation: Department of Internal Medicine & Medical Specialities, Sapienza University of Rome, Roma, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Violi
authors.affiliation: Clinical Pharmacology Unit, CNR Institute of Neuroscience, Department of Biomedical & Clinical Sciences, L. Sacco University Hospital, Università di Milano, Milano, Italy.|Scientific Institute IRCCS Eugenio Medea, Bosisio Parini, Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Clementi
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000097:blood* / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000097:blood / Q000188:drug therapy; D001774:Blood Chemical Analysis / Q000379:methods*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000069604:Dabigatran / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D011720:Pyrazoles / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D011728:Pyridones / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000925:Anticoagulants; D011720:Pyrazoles; D011728:Pyridones; C522181:apixaban; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: LC–MS/MS; anticoagulants; apixaban; bioanalytical method validation; dabigatran; rivaroxaban