Analysis of matrine and oxymatrine in kushensu injection by UPLC/Q-TOF-MS

Abstract

Objective: To develop a method for the determination of matrine and oxymatrine in Kushensu injection by ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC/Q-TOF-MS). Method: The analysis was performed on a Acquity UPLC BEH C18 column (2.1 mm x 100 mm, 1.7 μm) with the gradient elution of 10 mmol·L-1 amine acetate (pH 8, adjusted by aqueous ammonia) and methanol. The flow rate was set as 0.30 mL·min-1. The column temperature was maintained at 30°C. The peaks were detected at 210 nm and the injection volume was 2 μL. Result: The calibration curves showed good linearity within the test ranges of 0.084-3.36 μg for matrine and 0.086-3.44 μg for oxymatrine, respectively. The mean recoveries were 103.2%, 98.7 %, and the RSD were 1.5%, 1.2%, respectively. Conclusion: The established method is simple, rapid and sensitive, can be used for the quality control of matrine and oxymatrine in Kushensu injection through the manufacturing process and clinical implement.