title: Validation of a bioanalytical method for the quantification of a therapeutic peptide, ramoplanin, in human dried blood spots using LC-MS/MS.
abstract: A method has been developed and validated for the quantification of ramoplanin, a 2554 Da peptide antibiotic, in human dried blood spots using high-performance liquid chromatography with tandem mass spectrometric detection. The validation data meet FDA acceptance criteria for bioanalytical assays and cover the quantification of ramoplanin over the range 10-5000 ng/mL. The assay determines ramoplanin at the same lower limit of quantification as conventional liquid sample methods. Dried blood spot analysis provides an approach for quantification of peptide therapeutics and delivers significant benefits for sample collection and handling and also sample cleanup over conventional plasma and serum assays.
authors.affiliation: Covance Laboratories, Harrogate HG3 1PY, UK. matthew.ewles@covance.com
authors.forename: Matthew F
authors.initials: MF
authors.lastname: Ewles
authors.forename: Phillip E
authors.initials: PE
authors.lastname: Turpin
authors.forename: Lee
authors.initials: L
authors.lastname: Goodwin
authors.forename: David M
authors.initials: DM
authors.lastname: Bakes
mesh_terms: D000900:Anti-Bacterial Agents / Q000097:blood* / Q000627:therapeutic use; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D047630:Depsipeptides / Q000097:blood* / Q000627:therapeutic use; D004358:Drug Therapy; D006801:Humans; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000900:Anti-Bacterial Agents; D047630:Depsipeptides; C041438:ramoplanin