关键词: font-size:medium, ">磷酸苯丙哌林；环氧丙烷；二氯亚砜；基因毒性杂质；气相质谱联用法

Abstract: Objective： To develop a GC-MS method for the determination of Propylene oxide and Thionyl chloride in Benproperine phosphate. Methods： A TG-WAXMS column was adopted with a gradient elution system. SIM was adopted for mass spectrometry， and Ion source temperature was 230 ℃. Headspace sampling was used， the equilibrium temperature was 90 ℃， and the equilibrium time was 30 minutes. Results： Propylene oxide showed good linearity at 0.09-1.8 μg·mL-1， and thionyl chloride showed good linearity at 0.045 4-1.818 μg·mL-1. The recoveries of propylene oxide and thionyl chloride were 97.6% and 99.2%， respectively (n=9). The repeatability was 4.9% and 5.0%， respectively (n=6). No propylene oxide and thionyl chloride was detected in 10 batches of API. Conclusion：The method was sensitive and accurate， suitable for the quality control of propylene oxide and thionyl chloride in Benproperine phosphate.

Key words: font-size:medium, ">Benproperine phosphate； Propylene oxide； Thionyl chloride； Genotoxic impurity； GC-MS