Impact of sample hemolysis on drug stability in regulated bioanalysis

Abstract

Eugénie-Raphaëlle Bérubé obtained a Bachelor of Science in Biochemistry from University du Québec à Montreal. She previously worked at the St-Lawrence Center of Environment Canada, conducting biomarker analysis to measure the impact of contaminants on the aquatic species. She has been working in the bioanalysis industry for the past 7 years at Algorithme Pharma, a CRO located in Laval, Canada, becoming a scientist in bioanalytical method development for the quantitation of pharmaceuticals in biological fluids. Marie-Pierre Taillon holds a Bachelor of Science in Biochemistry. She is a senior scientist in method development at Algorithme Pharma; she has been working in the bioanalysis industry for the past 11 years where she became an expert in method development, specifically in the LC–MS/MS field. Her experiences have led her to conduct robust and effective method development of bioanalytical assays. 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.