盐酸替罗非班中残留溶剂的测定

目的建立盐酸替罗非班中残留溶剂的分离测定方法。方法采用气相色谱法，Agilent DB-624柱（30m×0．32mm，1．80μm），氢火焰离子化检测器，以氮气为载气，进样口温度为200，检测器温度为300℃；起始温度为40℃，保持20min，以每分钟20℃的速率升温至220℃，保持10min。结果被测溶剂均能得到良好的分离，每个溶剂的峰面积与浓度在一定的范围内能够呈现良好的线性关系。结论该方法能够准确测定盐酸替罗非班中的残留溶剂，可用于盐酸替罗非班原料药有机溶剂的检测。

Detection of residual solvents in tirofiban hydrochloride

Objective To establish a method for the detection of residual solvent in tirofiban hydrochloride. Methods The residual solvent in tirofiban hydrochloride was determined by GC with DB-624 capillary column （30 m×0.32 mm, 1.80 μm）;FID detector and nitrogen was used as the carries gas;the injector temperature and detector temperature was set to be 200℃ and 300℃ respectively;the column temperature was controlled by the automatic program;the initial temperature was set to be 40℃ and maintained for 20 min;then the temperature was risen to 220℃ with the rate of 20℃/min and maintained for 10 min. Results The result showed that the solvents were completely separated;the peak area and concentration of each solvent had good linear relationship within certain range. Conclusion This method is proved to be accurate and reliable for the accurate detection of residual solvent in tirofiban hydrochloride,It can be used in the detection for the organic solvent of tirofiban hydrochloride drug.