title: Impact of sample hemolysis on drug stability in regulated bioanalysis.
abstract: Being regulated by agencies' guidances, the importance of a robust validated bioanalytical method is crucial as it may impact the validity of the pharmacokinetic data generated. During blood collection and processing, the presence of hemolyzed plasma samples may occur and as a result its impact must be investigated to ensure method robustness. Indeed, hemolyzed samples may affect the analyte recovery efficiency, as well as the chromatography. Furthermore, the stability of an analyte in hemolyzed plasma can be an issue as analyte degradation may occur. In this article we report two case studies where the analyte instability was a result of sample hemolysis. A description of the appropriate actions undertaken for the resolution of the issue will be discussed.
authors.affiliation: Algorithme Pharma Inc., Laval (Montreal) Quebec, H7V 4B3, Canada.
authors.forename: Eugénie-Raphaëlle
authors.initials: ER
authors.lastname: Bérubé
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Taillon
authors.forename: Milton
authors.initials: M
authors.lastname: Furtado
authors.forename: Fabio
authors.initials: F
authors.lastname: Garofolo
mesh_terms: D002851:Chromatography, High Pressure Liquid; D003903:Deuterium / Q000737:chemistry; D004355:Drug Stability; D016666:Fluvoxamine / Q000097:blood / Q000737:chemistry; D006461:Hemolysis; D006801:Humans; D013058:Mass Spectrometry; D009020:Morphine / Q000097:blood / Q000737:chemistry; D004364:Pharmaceutical Preparations / Q000097:blood* / Q000737:chemistry
chemical_list: D004364:Pharmaceutical Preparations; D009020:Morphine; D003903:Deuterium; D016666:Fluvoxamine