头孢尼西钠残留溶剂检查法的研究

目的建立用气相色谱的顶空进样法测定头孢尼西钠中乙腈、二氯甲烷、四氢呋喃3种残留溶剂.方法用HP-INNOWAX毛细管柱(30m×0·53mm,1·0μm),以氮气为载气,FID检测器,顶空进样,通过外标法计算头孢尼西钠中的残留量.结果头孢尼西钠中3种溶剂残留在6~600μg?ml-1浓度范围有良好的线性关系,r≥0·9997,平均回收率为98·7%~103·2%,RSD为1·3%~1·8%.结论本法快速、简便、灵敏度高,分离度好.

Detection method study of the residual solvents in Cefonicid Sodium

OBJECTIVE To establish a method for determination residual acetonitrile,dichloromethane,tetrahydrofuran of Cefonicid Sodium by headspace GC.METHODS The GC was equipped with a flame-ionization detector for headspace injecting.A HP-INNOWAX(30m×0.53mm,1.0μm)chromatographic column was adopted.The carrier gas was nitrogen.Assay of residual solvents was calculated according to the external standard method.RESULTS Three residual solvents in Cefonicid sodium had good linear in the range of 6～600 μg·ml~ -1 (r≥0.9997).The average recovery was 98.7%～103.2%,with RSD 1.3%～1.8%.CONCLUSION The method is rapid,accurate and suitable for the determination of residual solvents in Cefonicid Sodium.