Indacaterol (IND), 5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one, is an active pharmaceutical ingredient (API) which is used to treat chronic obstructive pulmonary disease (COPD). We followed the International Council for Harmonization (ICH) guide lines to study the degradation behavior of IND under various stress conditions. Stressed degradation of the drug was performed under hydrolytic (alkaline, acidic and neutral), photolytic, oxidative and thermal conditions. Identification and characterization of IND and its forced degradation products (DPs) were demonstrated by using LC-HRMS and MS/MS method. A total of three DPs (DP1-DP3) were identified and characterized. The IND was found to be stable under photolytic, oxidative and thermal conditions, whereas it produced three DPs in acidic, basic and neutral hydrolytic stress conditions.

中文翻译：

---

使用液相色谱/质谱法鉴定和表征茚达特罗的降解产物

茚达特罗 (IND), 5-[2-[(5,6-Diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxyquinolin-2(1H)-one , 是一种活性药物成分 (API)，用于治疗慢性阻塞性肺病 (COPD)。我们遵循国际协调委员会 (ICH) 指南来研究 IND 在各种压力条件下的降解行为。药物的应力降解在水解（碱性、酸性和中性）、光解、氧化和热条件下进行。使用 LC-HRMS 和 MS/MS 方法对 IND 及其强制降解​​产物 (DP) 进行了鉴定和表征。总共确定和表征了三个 DP（DP1-DP3）。发现 IND 在光解、氧化和热条件下是稳定的，而它在酸性条件下产生三个 DP，