LC-MS/MS法鉴定替米沙坦氨氯地平双层片中有关物质  

Identification of the related substances in telmisartan/amlodipine double layer tablets by LC-MS/MS

作　　者：杨友田[1] 毛白杨 成黎霏 苏梦翔[3,4] 狄斌[3,4] 

机构地区：[1]盐城卫生职业技术学院,盐城224005 [2]常州市亚邦医药研究所有限公司,常州213163 [3]中国药科大学药物分析教研室,南京210009 [4]中国药科大学药物质量与安全预警教育部重点实验室,南京210009

出　　处：《中国药科大学学报》2014年第1期65-69,共5页Journal of China Pharmaceutical University

摘　　要：建立LC-MS/MS法对替米沙坦氨氯地平双层片的有关物质进行鉴定。双层片中的替米沙坦层及氨氯地平层分别取样和反相高效液相色谱线性梯度法分析测定,替米沙坦及氨氯地平均与其有关物质分离良好。检测出替米沙坦中14个有关物质峰,对其中主要7个有关物质经二级质谱测定和解析鉴定了它们的结构,同时检测出氨氯地平中2个为英国药典收载的有关物质。An LC-MS/MS method was established for the determination and identification of the related substances in telmisartan and amlodipine double layer tablets. Both sampling and HPLC separation of telmisartan and amlodipine were carried out separately using ODS column（250 mm×4. 6 mm, 5 μm）with linear gradient elution. Good resolution of telmisartan and amlodipine and their related substances were achieved. Fourteen related substances of telmisartan were detected and seven of them were elucidated. Two related substances of amlodipine were identified to be the same as those recorded in British Pharmacopoeia.

关 键 词：替米沙坦氨氯地平双层片 有关物质 LC-MS MS 鉴定 

分 类 号：R927.2[医药卫生—药学]