关键词: font-size:medium, ">桂利嗪原料药；残留溶剂；三氯甲烷；苯；气相色谱

Abstract: Objective： To establish GC method for determination of residual organic solvent Trichloromethane and Benzene in cinnarizine API. Methods： GC was used with DB-624(60 m×0.32 mm×1.80 μm) Capillary column. The detector was FID， Inlet temperature was 250 ℃. Temperature programming：the initial column temperature was 55 ℃， kept for 10 min，and then rised to 220 ℃ with a rate of 20 ℃·min-1and kept for 5 min. The detector temperature was 280 ℃. The flow rate was 3.0 mL·min-1； split ratio was 5∶1. Headspace sampling was used with an temperature of equilibrium at 90 ℃ and an equilibrium time 20 min. Results： The linear equations of trichloromethane(1.50-18.04 μg·mL-1) and benzene(0.050-0.603μg·mL-1) were in good linear range （r＞0.999）.The average recovery of trichloromethane and benzene were 97.5%（RSD=2.0%）and 97.7%（RSD=3.1%）. Conclusion：The method is sensitive and accurate with good reproducibility， which can be used to determine the contents of trichloromethane and benzene in cinnarizine API.

Key words: font-size:medium, ">Cinnarizine API；Residual solvent；Trichloromethane；Benzene；Gas chromatography