目的 建立氢溴酸替格列汀中遗传毒性杂质溴乙烷残留量的气相色谱（GC）检测方法。方法 采用迪马DM-624色谱柱（30 m×0.53 mm×3.0 μm）；电子捕获检测器（ECD）；程序升温：初始柱温40 ℃，保持3 min，以20 ℃/min升温至200 ℃，保持5 min；进样口温度：210 ℃；检测器温度：210 ℃；载气：氮气；分流比：3：1；进样量1 μL。结果 溴乙烷在0.75～6.75 μg/mL与峰面积呈良好的线性关系（r=0.999 7），最低检测限为0.26 μg/mL。平均回收率为99.4%，RSD值为0.3%（n=9）。3批氢溴酸替格列汀样品中均未检测出溴乙烷。结论 该方法简便、准确，重复性好，适用于氢溴酸替格列汀中溴乙烷残留量的控制。

Objective To establish a gas chromatography (GC) method for the determination of bromoethane residues in teneligliptin hydrobromide. Methods The determination was carried out on Dikma DM-624 chromatographic column (30 m × 0.53 mm, 3.0 μm) with ECD detector. The column temperature was raised from 40 ℃ (kept for 3 min) to 200 ℃ (then kept for 5 min) by program at the rate of 20 ℃/min. The injector temperature was 210 ℃, and the detector temperature was 210 ℃. Nitrogen was used as carrier gas. The injection volume was 1 μL with 3∶1 as split ratio. Results The linearity range of bromoethane was 0.75 — 6.75 μg/mL (r = 0.999 7). The minimum detectable limit was 0.26 μg/mL. The average recovery was 99.4% with RSD value of 0.3% (n = 9). Bromoethanes in three batches of teneligliptin hydrobromide samples were not detected. Conclusion The method is sample, accurate, reproducible, and applicable to the residues control of bromoethane in teneligliptin hydrobromide.