title: Assay development for determination of tenofovir in human plasma by solid phase analytical derivatization and LC-MS/MS.
abstract: BACKGROUND
  A novel method was developed and validated to measure tenofovir in human plasma. RESULTS/METHODOLOGY: This method employed solid phase analytical derivatization and analysis by LC-MS/MS. Stable-labeled internal standard was added to plasma samples followed by solid phase extraction. Retained analytes were derivatized on the solid phase extraction cartridges with a diazomethane solution to yield methyl-ester derivatives. Samples were analyzed using LC-MS/MS incorporating the use of a strong cation exchange column. The method was validated over a range of 5.00-750 ng/ml. The approach developed in this report for tenofovir could be applied to other analytes that share similar structural similarities.
  
  
  CONCLUSIONS
  The tenofovir LC-MS/MS method was used to support a clinical study of over 400 samples with a 100% success rate.
authors.affiliation: Antiviral Pharmacology Laboratory, University of Nebraska Medical Center, Omaha, NE 68198, USA.|Celerion, Inc., 621 Rose Street, Lincoln, NE 68502, USA.
authors.forename: Anthony T
authors.initials: AT
authors.lastname: Podany
authors.affiliation: Celerion, Inc., 621 Rose Street, Lincoln, NE 68502, USA.
authors.forename: Curtis
authors.initials: C
authors.lastname: Sheldon
authors.affiliation: Celerion, Inc., 621 Rose Street, Lincoln, NE 68502, USA.
authors.forename: Daryl
authors.initials: D
authors.lastname: Grafelman
authors.affiliation: Celerion, Inc., 621 Rose Street, Lincoln, NE 68502, USA.|PRA Health Sciences, 11070 Strang Line Road, Lenexa, KS 66215, USA.
authors.forename: Corey M
authors.initials: CM
authors.lastname: Ohnmacht
mesh_terms: D000998:Antiviral Agents / Q000097:blood*; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D052616:Solid Phase Extraction / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D000068698:Tenofovir / Q000097:blood*
chemical_list: D000998:Antiviral Agents; D000068698:Tenofovir