Characterisation of degradation products of tegoprazan by LC-MS and GC-MS

被引：1
|
作者：
Guo, Kaijing [1 ]
He, Xiao [1 ]
Zhao, Hongyi [1 ]
Ma, Chen [1 ]
机构：
[1] Chinese Acad Med Sci & Peking Union Med Coll, Inst Mat Med, Beijing 100050, Peoples R China
来源：
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2023年 / 228卷
关键词：
Tegoprazan; Stress testing; LC-HRMS; LC-MSn; GC-Q-TOF-MS; NMR; FORCED DEGRADATION; IDENTIFICATION;
D O I：
10.1016/j.jpba.2023.115323
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
Tegoprazan is a novel orally active potassium-competitive acid blocker (P-CAB), capable of binding to the K+ binding site of H+/K+-ATPase in a reversible way to inhibit gastric acid secretion. Tegoprazan has been approved for treating acid-related diseases. In this study, stress testings of tegoprazan were performed under various conditions, including hydrolysis (acidic, alkaline, and neutral), oxidation, photolysis, and thermal stress. Tego-prazan showed instability in acidic, alkaline, and oxidative conditions. Eight degradation products (DPs) were identified. The DPs were characterized by LC-HRMS, LC-MSn, or GC-Q-TOF-MS. Meanwhile, DP-1, DP-2 and DP-3 were successfully synthesized and confirmed by NMR. The degradation pathway of tegoprazan was summarized. To the best of our knowledge, this is the first study on the forced degradation of tegoprazan.
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页数：7
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