目的 建立气相色谱测定头孢西丁钠原料药中环己胺残留量的方法。方法 采用DB-624毛细管色谱柱,进样口温度180℃;FID检测器温度250℃;程序升温;载气：氮气。结果 环己胺在0.4--20μg/m L范围内线性关系良好,r=0.999 5,平均回收率96.7%（RSD=1.8%）,检测限和定量限分别为0.13μg/m L和0.27μg/m L。结论 本方法操作简单,准确度好,可用于头孢西丁钠原料药中环己胺残留量的测定。
Objective To establish a capillary gas chromatography method for the determination of residual solvent of cyclohexylamine in cefoxitin sodium bulk drug. Methods The determination was performed on a DB- 624 capillary column with temperature program. The injection port and detector temperature were 180 ℃ and 250 ℃, respectively. The carrier gas was nitrogen. Results The linear range for cyclohexylamine was 0.4-20 μg/mL （r--0.999 5）. The average recoveries were 96.7% （RSD = 1.8%）.The limit of detection and limit of quantitation were 0.13 μg/mL and 0.27 μg/mL, respectively. Conclusion The method is simple and has a good accuracy. It can be used for determination of residual solvent of cyclohexylamine in cefoxitin sodium bulk drug.
JOurnal of Modern Food and Pharmaceuticals