Objective:To establish a HPLC method for determination of SR-enantomer in bedaquiline fumarate.Methods:The method was determined by HPLC with Phenomenex Lux Cellulose-1(250 mm×4.6 mm,5 μm)chiral column.The mobile phase was ammonium acetate buffer(pH value 7.0)-methanol(40∶60,volume ratio),detection wavelength was 226 nm.The column temperature was 25 ℃.The flow rate was 0.5 mL/min.Results:The SR-enantiomer could be well separated from the main peak of bedaquiline fumarate with a suitable retention time,and the calibration curves showed a good linear relationship within a certain range.Conclusion:The method is accurate and reliable,has strong specificity,high sensitivity and good repeatability,and is suitable for the determination of SR-enantomer in bedaquiline fumarate.
维普
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