title: Development and validation of HILIC-ESI/MS/MS methods for simultaneous quantitation of several antipsychotics in human plasma and blood.
abstract: BACKGROUND
  Knowledge of antipsychotic drug levels at point of care (POC) may significantly aid therapeutic decision-making. To support the development of future POC devices and to validate the use of fingerstick capillary blood sampling, two robust hydrophilic interaction LC-ESI/MS/MS methods were developed and validated. Two PK studies were completed evaluating the correlation between fingerstick blood and plasma concentrations with corresponding venous blood and plasma concentrations for several commonly prescribed atypical antipsychotics and selected metabolites. Sensitive and reliable LC-MS/MS bioanalytical assays were developed to support these studies.
  
  
  RESULTS
  Three methods, requiring only 25-μl matrix volumes, were developed using supported liquid extraction with hydrophilic interaction LC-MS/MS detection and validated according to regulatory guidance.
  
  
  CONCLUSIONS
  Robust and efficient LC-MS/MS assays were established and were effective in providing antipsychotic drug matrix comparator results in the intended clinical studies.
authors.affiliation: Bioanalysis Department, Janssen Research and Development, A Division of Janssen, Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: De Meulder
authors.affiliation: Chromatographic Sciences Department, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230-3323, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Waldron
authors.affiliation: Chromatographic Sciences Department, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230-3323, USA.
authors.forename: Linge
authors.initials: L
authors.lastname: Li
authors.affiliation: Chromatographic Sciences Department, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230-3323, USA.
authors.forename: Marlking G
authors.initials: MG
authors.lastname: Peay
authors.affiliation: Chromatographic Sciences Department, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230-3323, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Tingler
authors.affiliation: Chromatographic Sciences Department, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230-3323, USA.
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Hidy
authors.affiliation: Bioanalysis Department, Janssen Research and Development, A Division of Janssen, Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.
authors.forename: Tom
authors.initials: T
authors.lastname: Verhaeghe
authors.affiliation: Chromatographic Sciences Department, PPD Laboratories, 2244 Dabney Road, Richmond, VA 23230-3323, USA.
authors.forename: Rand G
authors.initials: RG
authors.lastname: Jenkins
mesh_terms: D014150:Antipsychotic Agents / Q000097:blood* / Q000493:pharmacokinetics / Q000592:standards; D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000592:standards; D006207:Half-Life; D006801:Humans; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000592:standards
chemical_list: D014150:Antipsychotic Agents
keywords: HILIC; LC–MS/MS; SLE; antipsychotics; fingerstick blood sampling; method validation