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齐拉西酮新杂质的鉴定
Journal of Pharmaceutical and Biomedical Analysis ( IF 3.1 ) Pub Date : 2021-10-07 , DOI: 10.1016/j.jpba.2021.114416 Sunil R Murkute 1 , Girij P Singh 1 , S G Vasantharaju 2 , Krishnamurthy Bhat 2 , Himanshu M Godbole 1 , Pritesh R Upadhyay 1 , Anurag Trivedi 1
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更新日期:2021-10-20
Journal of Pharmaceutical and Biomedical Analysis ( IF 3.1 ) Pub Date : 2021-10-07 , DOI: 10.1016/j.jpba.2021.114416 Sunil R Murkute 1 , Girij P Singh 1 , S G Vasantharaju 2 , Krishnamurthy Bhat 2 , Himanshu M Godbole 1 , Pritesh R Upadhyay 1 , Anurag Trivedi 1
Affiliation
Ziprasidone hydrochloride 是第二代抗精神病药物,用于治疗精神分裂症和急性躁狂症或与双相情感障碍相关的混合发作。在扩大盐酸齐拉西酮的过程中,通过 HPLC-UV 分析在批次中观察到 0.10% 至 0.15% 的未知杂质。未知杂质的结构被提出为 3,3'-亚甲基双(5-(2-(4-(苯并[ d ]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-一)被命名为亚甲基齐拉西酮二聚体(MZD杂质)。通过制备型高效液相色谱法从富集样品中分离,并通过 HRMS、1D NMR ( 1 H, 13C)、DEPT-135、2D NMR(COSY、HSQC、HMBC)光谱。提出了形成孤立杂质的合理机制。
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