Identification,synthesis and characterization of an unknown process related impurity in eslicarbazepine acetate active pharmaceutical ingredient by LC/ESI-IT/MS,~1H,^(13)C and ~1H-~1H COSY NMR

查看全文 作　　者：Saji [1]Thomas;Saroj Kumar [1]Paul;Subhash Chandra [1]Joshi;Vineet [1]Kumar;Ashutosh [2]Agarwal;Dharam [2]Vir

机构地区：[1]Analytical Research Department,Jubilant Life Sciences Ltd.,R&D Centre,C-26,Sector-59,Noida,Uttar Pradesh 201301,India;[2]Chemical Research Department,Jubilant Life Sciences Ltd.,R&D Centre,C-26,Sector-59,Noida,Uttar Pradesh 201301,India

出　　处：《Journal of Pharmaceutical Analysis》索引2014年第4卷第5期,共6页

摘　　要：A new impurity was detected during high performance liquid chromatographic(HPLC) analysis of eslicarbazepine acetate active pharmaceutical ingredient.The structure of unknown impurity was postulated based on liquid chromatography mass spectrometry using electrospray ionization and ion trap analyzer(LC/ESI-IT/MS) analysis.Proposed structure of impurity was unambiguously confirmed by synthesis followed by characterization using ~1H,^(13)C nuclear magnetic resonance spectrometry(NMR),~1H-~1H correlation spectroscopy(COSY) and infrared spectroscopy(IR).Based on the spectroscopic and spectrometric data,unknown impurity was characterized as 5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl propionate. 关键词：相关杂质 HPLC COSY 药物成分 NMR MS 活性醋酸

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Identification,synthesis and characterization of an unknown process related impurity in eslicarbazepine acetate active pharmaceutical ingredient by LC/ESI-IT/MS,~1H,^(13)C and ~1H-~1H COSY NMR

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