Study On The Impurities Of Sartans

Sartan, also named Angiotensin II receptor blocker, is widely used as antihypertensive drugs on clinical application. This class of antihypertensive drugs has a better clinical curative effect, high bioavailability, long duration. They also can reverse target organ damage and reduce the risk of cardiovascular disease. Patients have good tolerance. As a kind of long-term using antihypertensive drugs, it is important to study the qulity of the drugs. The more complex of the production process, the more multiple of the impurities will be. For the synthesis of sartans mostly taking 5 to 10 steps, it is necessary to study the impurities to provide reference for quality control.This article summarized the impurity profiles of sartans, and confirmed the source of impurities. LC-MS method was established on the basis of existing liquid chromatographic conditions. The durability of the method was investigated and was considered good. Valsartan, irbesartan, candesartan cilexetil, telmisartan methyl ester, olmesartan medoxomil and azilsartan were studied by EI-MS and ESI-MS/MS. By analyzing the main fragment ions and the data of high resolution mass spectrometry, fragmentation pattens and regularities of sartans were summarized. Olmesartan medoxomil and azilsartan were analyzed by the established LC-MS method to ascertain target impurities. With the help of sartans’ mass fragmentation mechanism, this paper identified the structures of three unknown impurities in olmesartan medoxomil an five unknown impurities in azilsartan.