顶空气相色谱法测定头孢曲松钠中残留溶媒

Determination of the Residual Solvent Content in Ceftriaxone Sodium by Headspace Gas-chromatography Methods

目的:建立一种气相色谱法同时测定头孢曲松钠中有机溶剂甲醇、乙酸乙酯、异丙醇残留量的方法。方法:采用外标法顶空自动进样,在中极性弹性毛细管柱上进行分离,效果良好。结果:平均回收率甲醇98．6%- 102．6%;乙酸乙酯100．9%-103．8%;异丙醇98．3%-103．3%变异系数甲醇3．4%乙酸乙酯2．6%异丙醇2．4%。结论:方法重现性好,定量准确,便于操作。

Objective： Using the headspace Gas- chromatography methods to measure the assay of residual solvent （methanol, acetic ether and isopropyl alcohol） merwhile in Ceftriaxone sodium. Methods： auto-injection using standard headspace method, which make the component can be separated at the neutral polarity elastic capillary column, the result is good. Results： using the method can obtain a good repeatability, make the quantify accurate and make it is easy to operate. Conclnsion： the average recovery percentage： methanol 98.6% - 102.6%, acetic ether 100.9% - 103. 8%, and isopropyl alcohol 98.3% - 103.3%. Coefficient of variation： methanol 3.4%, acetic ether 2.6%, and isopropyl alcohol 2.4% .