[Analysis of matrine and oxymatrine in Kushensu injection by UPLC/Q-TOF-MS].

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 microm) with the gradient elution of 10 mmol x L(-1) amine acetate (pH 8, adjusted by aqueous ammonia) and methanol. The flow rate was set as 0.30 mL x min(-1). The column temperature was maintained at 30 degrees C. The peaks were detected at 210 nm and the injection volume was 2 microL. RESULT: The calibration curves showed good linearity within the test ranges of 0.084-3.36 microg for matrine and 0.086-3.44 microg 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.