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为探索一种利用质谱快速鉴定血管紧张素Ⅱ受体拮抗药中未知杂质结构的方法,采用电子轰击质谱(EI-MS)和电喷雾串联质谱(ESI-MS/MS)研究已上市的6种沙坦类药物。通过解析碎片离子并结合高分辨质谱确证裂解途径,总结沙坦类药物的质谱裂解规律,并将其应用于未知杂质结构的快速鉴定。据此鉴定了阿齐沙坦原料药中的2个未知的同分异构体杂质,杂质1为噁二唑环的氮原子被乙基化,杂质2为阿齐沙坦羧酸乙酯。
In order to explore a method for the rapid identification of unknown impurities in angiotensin Ⅱ receptor antagonists by mass spectrometry, six commercially available products were studied by EI-MS and ESI-MS / MS. Sartan drugs. By analyzing fragment ions and confirming the cleavage pathway by high resolution mass spectrometry, the rule of mass spectrometry cleavage of sartan was summarized and applied to the rapid identification of unknown impurity structure. According to this, two unknown isomeric impurities in azathione were identified. The impurity 1 was that the nitrogen atom of the oxadiazole ring was ethylated, and impurity 2 was azilsartan carboxylate.