Determination of Enantiomers in Sofobuvir Starting Material by RP-HPLC
Objective:To establish a method for the determination of the enantiomers of Sophobuvir starting material[(2R)-2-deoxy-2-fluoro-2-methyl-D-carboxylic acid γ-Lactone 3,5-Dibenzoate]. Methods:Daicel CHIRALPAK OJ-RH (4.6 mm×150 mm,5 μm) was used as chromatographic column. trifluoroacetic acid-acetonitrile-water(0.25∶680∶320) as mobile phase,and elute equally. The detection wavelength was 230 nm and the flow rate was 1.0 mL/min. Results:The specificity was good,and the linear relationship between enantiomers was good in the limit concentration range of 20％～200％,r ≥ 0.9999. The recovery was in the range of 97.7％～104.0％,RSD was less than 10.0％ (n=9),and preci-sion and repeatability RSD are less than 10.0％,good durability. Conclusion:This method has good precision and high accuracy,and can be used for the determination of enantiomers of this product.
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