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[Chiral separation of fluvastatin enantiomers with in vitro cellular method]
Bo-xuan Qu1, Ye Tian, Lu-shan Yu
1Department of Pharmaceutical Analysis and Drug Metabolism, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
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 (90:10:0.1) 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.
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