GC-MS法测定药物制剂中邻苯二甲酸酯类化合物的含量

目的建立盐酸雷尼替丁制剂中邻苯二甲酸酯类化合物的检测方法。方法以甲醇为溶剂制备溶液;采用GC-MS法检测,使用DB-5MS色谱柱,载气为氦气,流速为1.0 mL·min-1,检测方式为SCAN和SIR。结果实验条件下,20种邻苯二甲酸酯类化合物能很好分离检测;各组分的检测限（S/N=3）大于2μg·g-1,线性范围在2～40μg·mL-1之间,r〉0.99;加样回收率在79%～99%之间,RSD〈10.8%。结论本法操作简便、准确,分离效果好,对色谱柱和仪器污染小,进样残留少,可同时测定口服固体制剂中的20种邻苯二甲酸酯类化合物。

Determination of Phthalates in Ranitidine Hydrochloride Preparation by GC-MS

Objective To establish a GC-MS method for simultaneous determination of 20 kinds of phthalates in Ranitidine Hydrochloride preparation.Methods Phthalates were extracted with methanol;the analysis was performed by GG-MS SCAN and SIR;DB-5MS capillary column was adopted with Helium as carrier gas with a flow rate of 1.0 mL·min-1.Results Twenty kinds of phthalates could be completely separated under the selected conditions.The limits of detection were above 2 μg·g-1;The linear range were 2-40 μg·mL-1,r>0.99;and the average recoveries were 79%-99%,RSD<10.8%.Conclusion This detection method is simple,accurate,and reproducible,which can be applied in the determination of phthalates esters in oral preparation.