气相色谱法测定去水卫矛醇原料及其制剂的有关物质  

Determination of the Related Substances in Dianhydrodulcitol and its Preparations by Capillary Gas Chromatography

作　　者：孙逍 谢升谷 陈悦 SUN Xiao;XIE Sheng-gu;CHEN Yue(Zhejiang Institute for Food and Drug Control,Hangzhou 310004,China)

机构地区：[1]浙江省食品药品检验研究院国家药品监督管理局仿制药评价关键技术重点实验室

出　　处：《海峡药学》2019年第9期94-96,共3页Strait Pharmaceutical Journal

基　　金：国家重大科技专项药物一致性评价关键技术与研究(编号:2017ZX09101001)

摘　　要：目的 建立毛细管气相色谱法测定去水卫矛醇及其制剂中有关物质的方法,以便更好的控制其质量。方法 样品经甲醇稀释,采用分流法进样,以DB-1毛细管色谱柱(30m×0.32mm,1.0μm)为分析柱,程序升温,进样口温度为150度,FID检测器,载气为氮气,测定去水卫矛醇原料药及其注射用制剂有关物质含量。结果有关物质与主药分离良好,原料药及注射用制剂中有关物质总杂质含量均小于2.0%,单一杂质含量均小于1.0%。结论 本方法方便准确、灵敏、可靠,可用于考察去水卫矛醇原料及其制剂的杂质变化情况。OBJECTIVE A capillary Gas chromatography method was established for the determination of the related Substances in Dianhydrodulcitol and its preparations in order to better control the quality. METHODS Determination of the related Substances in dianhydrodulcitol and its preparations was performed on a DB-1 capillary column (30m×0.32mm,1.0μm) with column temperature programmed.The solution was prepared by methanol,introduced into GC by split injection;injector temperature is 150℃,with FID detector,nitrogen as the caries gas. RESULTS Dianhydrodulcitol and its related substances were separated.The contents of total impurities in dianhydrodulcitol and its preparations were all not more than 2.0% and single impurity not more than 1.0%. CONCLUSION The method is accurate,sensitive and suitable for the determination of the related substances.

关 键 词：去水卫矛醇 气相色谱 有关物质 

分 类 号：R927[医药卫生—药学]