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.
LOU Yan-hua
,
HOU Jian-jun
,
LIU Zi-wei
,
HAN Yi
,
LI Hong-wei
. Ratio of enantiomer in fluralaner by HPLC[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(10)
: 1789
-1794
.
DOI: 10.16155/j.0254-1793.2024-0061
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