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目的建立头孢地尼中5种残留有机溶剂(甲醇、三乙胺、乙腈、甲苯、N,N-二甲基乙酰胺)的分离测定方法。方法采用GC法测定,毛细管柱为HP-FFAP(30 m×0.53 mm,1.00μm),以氮气为载气,FID检测器,采用程序升温,柱温为80℃,保持5 min,以20℃.min-1升至200℃,保持5 min,进样口温度为200℃,检测器温度为250℃,分流直接进样,用外标法计算残留溶剂的含量。结果 5种残留成分的峰面积和浓度在测定范围内均具有良好的线性关系,进样精密度的RSD<4.0%,平均回收率为97.1%～99.4%。结论所用方法简单准确、灵敏度好,适用于同时测定头孢地尼中5种残留的有机溶剂。
OBJECTIVE To establish a method for the separation and determination of five residual organic solvents (methanol, triethylamine, acetonitrile, toluene, N, N-dimethylacetamide) in cefdinir. Methods The GC method was used. The capillary column was HP-FFAP (30 m × 0.53 mm, 1.00 μm). Nitrogen gas was used as the carrier gas and FID detector. The temperature of the column was 80 ℃ and kept for 5 min at 20 ℃ . Min-1 was raised to 200 ° C for 5 min. The temperature of the inlet was 200 ° C and the detector temperature was 250 ° C. Direct injection was performed by split flow and the residual solvent content was calculated by external standard method. Results The peak area and concentration of the five residual components all had a good linear relationship within the measurement range. The precision of injection was lower than 4.0% and the average recovery was 97.1% ~ 99.4%. Conclusion The method is simple, accurate and sensitive. It is suitable for the simultaneous determination of five residual organic solvents in cefdinir.