气相色谱法测定头孢地嗪钠残留溶剂

Detection of Residual Solvents in Cefodizime Sodium Using Gas Chromatography

目的:建立头孢地嗪钠残留溶剂的检测方法。方法:采用DB-624毛细管柱,柱温40℃;载气为氮气;氢火焰离子化检测器,检测器温度为250℃;进样口温度为160℃;溶液直接进样。结果:被测各溶剂均能良好分离,各溶剂峰面积与浓度均呈良好的线性关系;方法的精密度良好;回收率较为理想。结论:气相色谱法适用于头孢地嗪钠的残留溶剂检测。

Objective： To establish a method for detection of the residual solvents in cefodizime sodium. Methods： The residual solvents in this material were determined by gas chromatography equipped with 4 flame ionization detector （FID） and linked with Agilent DB-624 capillary column（30 m ×0.53 mm× 3.0 μm）. The carrier gas was highly purified nitrogen. The inlet temperature was 160 ℃ and the FID detector temperature was 250 . The column temperature was 40 ℃, and the injection volume was 1.0 μl. Resuits： Each solvent could be completely separated in chromatogram obtained from systemic suitability test, and the calibration curves of each solvent had good linear relationship within a certain range. Conclusion： The method is accurate and reliable. It can be applied in the detection of residual solvents in cefodizime sodium material.