Department of Analytical and Structural Chemistry, CSIR-Indian Institute of Chemical Technology, Hyderabad, India.
Academy of Scientific and Innovative Research, Ghaziabad, India.
Eur J Mass Spectrom (Chichester). 2020 Dec;26(6):425-431. doi: 10.1177/1469066720971550. Epub 2020 Nov 5.
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.
吲达特罗（IND），5-[2-[(5,6-二乙基-2,3-二氢-1H-茚-2-基)氨基]-1-羟乙基]-8-羟基喹啉-2(1H)-酮，是一种活性药物成分（API），用于治疗慢性阻塞性肺疾病（COPD）。我们遵循国际协调委员会（ICH）的指导原则，研究了 IND 在各种应激条件下的降解行为。在水解（碱性、酸性和中性）、光解、氧化和热条件下对药物进行了强制降解。通过 LC-HRMS 和 MS/MS 方法证明了 IND 及其强制降解产物（DP）的鉴定和表征。共鉴定和表征了三个 DP（DP1-DP3）。IND 在光解、氧化和热条件下稳定，而在酸性、碱性和中性水解应激条件下生成了三个 DP。
