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目的建立盐酸头孢卡品酯中7种有机溶剂的分离测定方法。方法采用顶空进样毛细管气相色谱法,FID检测器,运用DB-1毛细管柱(30.0m×0.53mm,1.5μm)为色谱柱,氮气为载气,采取程序升温,初始柱温40℃,保持10min,再以20℃/min的速率升至80℃,保持5min。测定了盐酸头孢卡品酯中丙酮、乙醇、乙酸乙酯、二氯甲烷、甲基异丁基酮、四氢呋喃和N、N-二甲基甲酰胺的残留量。结果各有机溶剂均能得到有效的分离,在所考察的溶度范围内线性关系良好,R2为0.9988～0.9999,平均回收率为96.7%～103.3%。结论本方法灵敏、准确、可靠,可用于盐酸头孢卡品酯的质量控制。
Objective To establish a method for the separation and determination of seven organic solvents in cefotaxime hydrochloride. Methods Headspace injection capillary gas chromatography with FID detector was used. The column temperature was 40 ℃ with DB-1 capillary column (30.0m × 0.53mm, 1.5μm) as the carrier gas and nitrogen as the carrier gas. Hold for 10 min, then ramped to 80 ° C at 20 ° C / min for 5 min. The residual amounts of acetone, ethanol, ethyl acetate, methylene chloride, methyl isobutyl ketone, tetrahydrofuran and N, N-dimethylformamide in cefotaxime hydrochloride were determined. As a result, each organic solvent can be effectively separated, and the linearity was good within the investigated solubility range. The R2 was 0.9988-0.99999 and the average recovery was 96.7% -103.3%. Conclusion The method is sensitive, accurate and reliable and can be used for the quality control of cefotaxime hydrochloride.