Migration of antioxidant from pharmaceutical halogenated butyl rubber stopper to tranexamic acid injection determined by HPLC
OBJECTIVE To establish a method for the determination of 11 antioxidants in tranexamic acid injection which could migrate from pharmaceutical halogenated butyl rubber stopper.METHODS HPLC was performed on Waters Symmetry C18(250 mm×4.6 mm,5 μm)column with acetonitrile(A)-methanol(B)-1％acetic acid solution(C)as the mobile phase with gradient elution at the flow rate of 1.0 mL·min-1.The detection wavelength was 277 nm and the column temperature was 35℃.The sample volume was 10 μL.RESULTS The resolution of the 11 antioxidants was great,and all antioxidants showed good linear relationship in the concentration range of 1.6-80 μg·mL-1(r2＞0.9950).The recoveries of the samples were 90.7％-107.4％,and the reproducibility of the method was good.A total of 15 batches of samples from 6 companies,including samples damaged by high temperature factors,only BHT-COOH was detected,and other antioxidants were all lower than the detection limit of drug methods.CONCLUSION The method has high sensitivity and good repeatability,can be used for the determination of the migration amount of 11 antioxidants from pharmaceutical halogenated butyl rubber stopper to tranexamic acid injection.
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