目的: 建立氟雷拉纳对映异构体比例的高效液相色谱测定方法。方法: 采用CHIRALPAK AD-H手性色谱柱(250 mm×4.6 mm,5 μm);以正己烷-无水乙醇(60∶40)为流动相,流速1.0 mL·min-1,检测波长265 nm,柱温室温,进样量20 μL。结果: 在本文色谱条件下,测定的3批样品,R-氟雷拉纳与S-氟雷拉纳峰面积的比例均为1∶1,R-氟雷拉纳与S-氟雷拉纳质量浓度分别在80.288~187.338 μg·mL-1(r=0.999 7)和81.902~191.104 μg·mL-1(r=0.999 9)范围内与峰面积呈良好的线性关系,平均回收率分别为100.6%和100.8%。结论: 本方法准确度高,重复性好,可用于氟雷拉纳外消旋体中对映异构体的比例测定方法。
Objective: To establish an HPLC method for the ratio of the enantiomer in fluralaner. Methods: The chromatographic separation was performed on chiral chromatography column CHIRALPAK AD-H (250 mm×4.6 mm,5 μm). The mobile phase consisted of nhexane-anhydrous ethanol (60∶40) and the flow rate was 1.0 mL·min-1. The detection wavelength was 265 nm and the column temperature was room temperature. Results: Under this chromatographic condition, three batches of samples were determined, the proportions of R-fluralaner and S-fluralaner were 1∶1. The calibration curves of R-fluralaner and S-fluralaner good linearities at the range of 80.288-187.338 μg·mL-1(r=0.999 7) and 81.902-191.104 μg·mL-1(r=0.999 9), respectively. The average recoveries were 100.6% and 100.8%. Conclusion: The method is accurate, reproducible and can be used for the ratio of enantiomers in fluralaner racemate.
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