title: Characterization of a novel process-related impurity in commercial bendazac lysine eye drops by LC-ESI-QTOF/MS/MS and NMR.
abstract: A simple and sensitive method was developed for characterization of two impurities from commercial bendazac lysine eye drops, by using liquid chromatography combined with electrospray ionization and QTOF mass analyzer (LC-ESI-QTOF MS/MS). A known impurity was characterized rapidly by comparison with the retention time and MS/MS data of the reference standard. Based on high resolution mass spectrometry (HRMS) and the nuclear magnetic resonance (NMR), a new impurity, purified by preparative HPLC, was identified as 2-(1,5-dibenzyl-1H-indazol-3-yloxy)acetic acid. In addition, a plausible mechanism for the formation of the impurities was also proposed.
authors: Zhejiang Institute for Food and Drug Control, Hangzhou 310004, Zhejiang, China.
authors: Peixi
authors: P
authors: Zhu
authors: Zhejiang Institute for Food and Drug Control, Hangzhou 310004, Zhejiang, China.
authors: Weifeng
authors: W
authors: Yang
authors: Zhejiang Institute for Food and Drug Control, Hangzhou 310004, Zhejiang, China. Electronic address: hongliya@zjyj.org.cn.
authors: Liya
authors: L
authors: Hong
authors: Zhejiang Institute for Food and Drug Control, Hangzhou 310004, Zhejiang, China.
authors: Qiaoyuan
authors: Q
authors: Cheng
authors: Zhejiang Institute for Food and Drug Control, Hangzhou 310004, Zhejiang, China.
authors: Lei
authors: L
authors: Luo
authors: Zhejiang Institute for Food and Drug Control, Hangzhou 310004, Zhejiang, China.
authors: Jiajia
authors: J
authors: He
authors: School of Marine Sciences, Ningbo University, Ningbo 315211, Zhejiang, China. Electronic address: chenjuanjuan@nbu.edu.cn.
authors: Juanjuan
authors: J
authors: Chen
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination; D007191:Indazoles / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D009883:Ophthalmic Solutions / Q000032:analysis* / Q000737:chemistry*; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods; D053719:Tandem Mass Spectrometry / Q000379:methods
chemical_list: D007191:Indazoles; D009883:Ophthalmic Solutions; C036067:bendazac lysine
keywords: Bendazac lysine; Eye drops; LC–MS; NMR; Unknown impurity