title: Potentially new isobaric metabolite of fluvastatin observed by LC-MS/MS during incurred sample analysis.
abstract: BACKGROUND
  Fluvastatin (Lescol(®)) is a racemic mixture of two erythro stereoisomers and metabolizes into two threo stereoisomers. A method was developed to chromatographically separate fluvastatin from its threo isomers to support a bioequivalence study.
  
  
  RESULTS
  During incurred samples analysis, an additional peak sharing the same mass transition as fluvastatin was observed and interfered with fluvastatin's quantification. Consequently, the chromatographic conditions were modified in order to resolve fluvastatin and the interference. Extensive evaluations were performed to ensure that the interference is not a degradation product generated during sample processing.
  
  
  CONCLUSIONS
  An isobaric compound of fluvastatin was discovered, which required chromatographic separation from fluvastatin to obtain a reliable bioanalytical method. The investigation performed suggests that the interference is produced in vivo and is a possible metabolite of fluvastatin.
authors: Algorithme Pharma Inc., 575 Armand-Frappier Blvd., Laval (Montréal), Quebec, H7V 4B3, Canada.
authors: Marie-Pierre
authors: MP
authors: Taillon
authors: Cynthia
authors: C
authors: Côté
authors: Milton
authors: M
authors: Furtado
authors: Fabio
authors: F
authors: Garofolo
mesh_terms: D000924:Anticholesteremic Agents / Q000097:blood / Q000737:chemistry; D002853:Chromatography, Liquid / Q000379:methods; D005229:Fatty Acids, Monounsaturated / Q000097:blood* / Q000737:chemistry*; D000077340:Fluvastatin; D006801:Humans; D007211:Indoles / Q000097:blood* / Q000737:chemistry*; D008297:Male; D013058:Mass Spectrometry / Q000379:methods; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013237:Stereoisomerism
chemical_list: D000924:Anticholesteremic Agents; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D000077340:Fluvastatin