头孢硫脒中3种有机溶剂残留量的测定

目的建立头孢硫脒中3种有机溶剂残留量的分离测定方法。方法采用顶空进样毛细管气相色谱法,hp-5毛细管柱,载气为氮气,FID检测器,水为溶解介质,二氯乙烷为内标物,检测了头孢硫脒原料药中乙醇、丙酮、二氯甲烷的残留量。结果乙醇、丙酮、二氯甲烷的检测限分别为0.12,0.08,0.25μg,精密度RSD均小于5%,平均回收率为99.35%～103.61%。结论本试验建立的色谱方法简便、灵敏,结果准确、重现性好,适用于头孢硫脒中乙醇、丙酮、二氯甲烷残留量的检测。

Determination of three residual solvents in Cefathiamidine

OBJECTIVE To establish a method for determination of three residual solvents in Cefathiamidine.METHODS The residual solvents which were ethanol,acetone,dichloromethane were quantitatively determined by headspace capillary GC on hp-5 column,water as solvent media,with FID detector,nitrogen,as the carrier gas.RESULTS The detection limit of ethanol,acetone,dichloromethane were 0.12,0.08,0.25μg;the RSD of precision was less than 5%;the average recovery rate of the preparation were in the range of 99.35%～103.61%.CONCLUSION The method was simple,sensitive,accurate and can be used for the quality control of three residual solvents of Cefathiamidine.