Potentially new isobaric metabolite of fluvastatin observed by LC-MS/MS during incurred sample analysis.

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. CONCLUSION 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.

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