目的建立超高效液相-二极管阵列-离子阱-飞行时间串联质谱(UPLC-DAD-IT-TOF-MS)法分离鉴定甘草酸二铵肠溶片中相关杂质的分析方法。方法采用Agilent HC-C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-水-冰醋酸(380∶614∶6)为流动相等度洗脱样品,体积流量1 m L/min,紫外检测波长254 nm,质谱监测质荷比范围m/z 100~1 000。结果分离鉴定出甘草酸皂苷G2、H2、E2、B2、J2、C2及18α-甘草酸、乌拉尔甘草皂苷(A或B)8种有关物质。结论研究结果为甘草酸二铵肠溶片的质量控制和工艺优化提供了依据,同时为中药制剂的杂质鉴定提供可借鉴的分析思路。 OBJECTIVE To establish a method for the separation and identification of related impurities in the diammonium glycyrrhizinate enteric-coated tablets by ultra performance liquid chromatography-diode array-ion trap-time of flight mass spectrometry (UPLC-DAD-IT-TOF- Methods The sample was eluted on an Agilent HC-C18 (250 mm × 4.6 mm, 5 μm) column with isocratic mobile phase of acetonitrile-water-glacial acetic acid (380:614:6) at a flow rate of 1 mL / The wavelength is 254 nm. The mass-to-mass ratio of mass spectrometry is in the range of m / z 100-1000. Results Eight related substances of glycyrrhizin G2, H2, E2, B2, J2, C2, 18α-glycyrrhizin and Ural glycyrrhizin (A or B) were isolated and identified. Conclusion The results provide the basis for the quality control and process optimization of diammonium glycyrrhizinate enteric-coated tablets, and provide reference for the identification of impurities in traditional Chinese medicine preparations.