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目的:对药用辅料甘油样品中的未知杂质进行质谱确证。方法:采用GC-MS法,VF-624ms毛细管柱(30 m×0.32 mm,1.8μm);柱温:起始温度120℃,维持3 min,以50℃·min~(-1)升至140℃,维持5 min,再以10℃·min~(-1)升至220℃,维持20 min;EI源温度:230℃。结果:样品中未知杂质确认为以不同方式聚合而成的二聚甘油。结论:该方法可用于药用辅料甘油中未知杂质的定性检测。
OBJECTIVE: To confirm the unknown impurities in glycerol sample of medical excipients. Methods: The capillary column (30 m × 0.32 mm, 1.8 μm) was operated on a VF-624ms column with GC-MS. The column temperature was 120 ℃ for 3 min and then increased to 140 at 50 ℃ · min -1 ℃, maintained for 5 min, and then raised to 220 ℃ at 10 ℃ · min ~ (-1) for 20 min; EI source temperature: 230 ℃. Results: Unknown impurities in the sample were identified as dimerized glycerol polymerized in different ways. Conclusion: This method can be used for the qualitative detection of unknown impurities in pharmaceutical excipients glycerol.