顶空气相色谱法测定地塞米松磷酸钠中有机溶剂的残留量

DETERMINATION OF ORGANIC SOLVENT RESIDUES IN DEXAMETHASONE SODIUM PHOSPHATE BY HEADSPACE GAS CHROMATOGRAPHY

采用顶空气相色谱法测定地塞米松磷酸钠中甲醇、丙酮等有机溶剂的残留量。最佳平衡温度为50℃,最佳平衡时间为70 m in,甲醇、丙酮在3 m in内分离良好,线性相关系数分别为0.999 6、0.999 7,平均回收率分别为102.2%、101.3%,测定结果的相对标准偏差分别为1.5%、1.8%(n=5)。

The headspace gas chromatographic method was applied to determine the residual solvent of methanol and acetone in dexamethasone sodium phosphate. The optimized equilibrium temperature was 50℃ and the equilibrium time was 70 min. The results indicated that methanol and acetone were separated perfectly within 3 min in experimental conditions. The correlation coefficient of the linear equation were 0.999 6, 0. 999 7, the average recoveries were 101.3% - 102.2 % , and the relative standard deviations were 1.5% -1.8%（n= 5）.