HPLC-QTOF MS analysis of impurities in epinephrine and epinephrine hydrochloride injection

Objective:To develop an HPLC-QTOF MS method for analysis of impurities in epinephrine and epinephrine hydrochloride injection.Methods:An Eclipse plus C18 column(3.0 mm×100 mm,1.8 μm) was utilized.The mobile phase was 5 mmol·L-1 ammonium formate aqueous solution(5 mmol·L-1)-formic acid aqueous solution(0.1%)(A) or acetonitrile(B).The velocity was 0.3 mL·min-1.The gradient elution was carried out in the following conditions:0→4 min,2% B;4→10 min,2%-50% B;10→12 min,50%-90%B;12→15 min,90%B.The column temperature was 30 ℃.The data was collected in positive ion mode.Results:Three impuries were found in epinephrine and epinephrine hydrochloride injection.They were adrenalone,sulfonated epinephrine and 4-[2-(butyl-2-ylamino)-1-hydroxyethyl]phenol.Conclusion:The method is simple,sensitive and accurate.It can be used for the qualitative analysis of impurities in epinephrine and epinephrine hydrochloride injection.