ABSTRACT
This study was aimed to establish a method for the rapid content determination of Ixerin Z and 11,13α-dihydroixerin Z in Ku-Die-Zi (KDZ) injection by UPLC-ESI-MS/MS. The separation was performed on a Waters ACQUITY BEH C18 column (2.1 mm × 50 mm, 1.7μm) by using a gradient elution with the mobile phase of acetonitrile-water at the flow rate of 0.4 mL·min-1. The column temperature was set at 40℃. Multi-reaction moni-toring (MRM) scanning was employed for quantification in ESI negative mode. The results showed that two sesquit-erpene lactones in KDZ injection were totally separated within 2 min. The linear range of Ixerin Z was 5.70-182.50 ng·mL-1, and the linear range of 11,13α-dihydroixerin Z was 4.60-131.25 ng·mL-1. The correlation coefficient r was more than 0.999 0. The recovery rates (n = 6) were 98.18% and 97.52%, with RSDs < 1.5%. The established method was successfully applied for simultaneous content determination of Ixerin Z and 11,13α-dihydroixerin Z in 6 batches of KDZ injection from 2 factories, which had some variations on the content determination results. It was concluded that the method was rapid, accurate and sensitive, which can be used for the content determination of two sesquiterpene lactones in KDZ injection.