目的 建立超高效液相色谱–质谱联用（UPLC-MS）法测定注射用丁二磺酸腺苷蛋氨酸中高丝氨酸内酯。方法 采用Waters ACQUITY XSelect HSS T3色谱柱（100 mm×2.1 mm，1.8 μm）；流动相为5 mmol/L甲酸铵水溶液–乙腈（98∶2）；柱温：30 ℃；体积流量：0.3 mL/min；样品室温度：10 ℃；进样量：2 μL。质谱检测器采用电喷雾离子源（ESI）正离子模式；采集离子：102.0；毛细管电压：0.8 kV；孔电压：15 V。结果 高丝氨酸内酯在0.102 3～20.460 0 ng与峰面积呈良好的线性关系（r＝0.999 8）。平均回收率为100.91%，RSD值为3.39%（n＝9）。结论 方法专属性强、灵敏度高、准确度好，为注射用丁二磺酸腺苷蛋氨酸的质量控制提供参考。

Objective To establish a method for determining homoserine lactone in Ademetionine 1,4-Butanedisulfonate for injection by ultra-performance liquid chromatography-mass spectrometry (UPLC-MS) method. Methods The chromatography was performed on Waters ACQUITY XSelect HSS T3 column (100 mm × 2.1mm, 1.8 μm) with a mobile phase of 5 mmol/L ammonium formate aqueous solution - acetonitrile (98∶2). The flow rate was 0.3 mL/min, the column temperature was 30 ℃, the sample chamber temperature was 10 ℃, and the injection volume was 2 μL. Mass spectrometry detection employed an electrospray ionization (ESI) source in positive ion mode, with selected ion monitoring at m/z 102.0, capillary voltage: 0.8 kV, and pore voltage: 15 V. Results The concentration of homoserine lactone showed good linearity within the range of 0.102 3 — 20.460 0 ng (r = 0.999 8). The average recovery rate was 100.91% with an RSD value of 3.39% (n = 9). Conclusion This method is specific, accurate, and sensitive, providing a reference for the quality control of Ademetionine 1,4-Butanedisulfonate for injection.

R927.2