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Determination of fluvastatin and its five metabolites in human plasma using simple gradient reversed-phase
A Nakashima1, C Saxer, M Niina
1Tsukuba Research Institute, Novartis Pharma K.K., Ibaraki, Japan. akinori.nakashima@pharma.novartis.com
Abstract:
A simple gradient reversed-phase high-performance chromatographic method with ultraviolet detection for the determination of fluvastatin (FV) and its five metabolites, (M-2, M-3, M4, M-5 and M-7) in human plasma was developed and validated. The limit of quantification of FV and its five metabolites in human plasma was 10 ng ml(-1). The assay had satisfactory selectivity, recovery, linearity and precision accuracy. Stability studies showed that FV and its five metabolites were stable in plasma up to at least 1 month of storage at -30 degrees C.