Simultaneous Determination of Thirteen Main Components and Identification of Eight Major Metabolites in Xuebijing Injection by UPLC/Q-TOF

Abstract

An ultra performance liquid chromatographic method was used for the simultaneous identifica tion and quantification of thirteen main components in Xuebijing Injection, including uridine, gallic acid, guanosine, danshensu, protocatechualdehyde, oxypaeoniflorin, hydroxysafflor yellow A, paeoniflorin, feru lic acid, safflor yellow A, senkyunolide I, senkyunolide H and salvianolic acid B. The chromatographic sep aration was performed on an Acquity UPLC BEH C18 column (1.7 μm, 2.1 × 100 mm, i.d.) with a gradient elution of acetonitrile and 0.2% acetic acid at a flow rate of 0.4 mL/min. The method was validated for lin earity (r2 > 0.9990), intra and inter day precision (RSD < 1.94%), accuracy (91.8⎯99.7%), recovery (96.8⎯103.8%), limits of detection (0.16⎯8.0 ng), and limits of quantification (0.54⎯26.8 ng). At least eight metabolites in prototype were found in rat plasma and urine after intravenous injection of 4 mL/kg doses of Xuebijing Injection. The proposed method could be utilized to qualify and control Xuebijing Injection to ensure its safety and efficacy in application.