[Chiral separation of fluvastatin enantiomers with in vitro cellular method].

ABSTRACT

OBJECTIVE: To establish a chiral separation method for determination of fluvastatin enantiomer with in vitro cellular model. METHODS: The determination was performed on Chiralpak AD column (4.6 mm × 250 mm); and the phase consisted of hexane-isopropanol-trifluoroacetic acid (90100.1) at a flow rate of 0.5 ml/min with UV detection of 239 nm. RESULT: The standard curve was linear over the concentration range of 20 µmol/L-300 µmol/L (r² = 0.9993, r² = 0.9997). The recovery for this assay was (99.4 ± 0.8)%, precision for inter-assay and intra-assay was <10 %. CONCLUSION: The normal-phase HPLC chiral separation method was accurate and suitable for study on the stereoselectivity of fluvastatin with in vitro cellular model.