气相色谱法检测头孢呋辛钠原料药中2-乙基己酸残留量

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目的:建立一种测定原料药头孢呋辛钠中2-乙基己酸有机溶剂残留量的气相色谱法.方法:改良药典通则中的前处理方法,以3-环己基丙酸作为内标,选择强极性色谱柱(聚乙二醇毛细管柱),FID检测器,程序升温法控制.结果:2-乙基己酸在0.00152~3.0458mg/mL范围内线性良好,相关系数r达到0.9998;低、中、高三个浓度的加样回收率介于89.36%~100.81%之间,相对标准偏差(RSD)值为4.55%.限度浓度溶液连续进样六次,RSD值为3.01%.结论:该方法系统适用性良好、灵敏度高、准确度、重复性良好,适用于头孢呋辛钠原料药中2-乙基己酸含量检查.
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