Stability-indicating reversed-phase HPLC method development and characterization of impurities in vortioxetine utilizing LC-MS, IR and NMR
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- 作者：Lei Liua ; Na Caoa ; Xingling Maa ; Kaihe Xiongb ; Lili Sunb ; Qiaogen Zoua ; qiaogenzou@hotmail.com" class="auth_mail" title="E-mail the corresponding author ; Lili Yaoc
- 关键词：ACN ; acetonitrile ; ESI ; electrospray ionization source ; Imp-A ; 1-[4-[(2 ; 4-dimethylphenyl)thio]phenyl]-piperazine ; Imp-B ; 1-[2-[(2 ; 4-dimethylphenyl)sulfinyl]phenyl]-piperazine ; Imp-C ; 1-(4-bromophenyl)piperazine ; Imp-D ; 1-(2-bromophenyl)piperazine ; Imp-E ; 1-[2-[(2 ; 6-dimethylphenyl)thio]phenyl]-piperazine ; SMA ; starting material A ; SMB ; starting material B ; SMC ; starting material C ; R ; resolution ; r ; regression ; RRT ; relative retention time ; %RSD ; relative standard deviation
- 刊名：Journal of Pharmaceutical and Biomedical Analysis
- 出版年：2016
- 出版时间：5 January 2016
- 年：2016
- 卷：117
- 期：Complete
- 页码：325-332
- 全文大小：1237 K
文摘
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Imp-A, a new compound, was found and identified by NMR, MS, and IR analyses.
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Identification and characterization of process-related impurities.
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The pathway for the formation of the impurities has been discussed.
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A RP-HPLC method is developed for quantitatively determining impurities.