双纳美芬杂质检查用定位溶液的研制
Development of bisnalmefene positioning solution for impurity detection
分类号：
出版年·卷·期（页码）：2016,36 (10):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的：建立双纳美芬杂质检查用定位溶液，以控制盐酸纳美芬原料和制剂中的双纳美芬。方法：取盐酸纳美芬对照品在酸性条件下用三氯化铁催化，水浴加热制得双纳美芬定位溶液，此定位溶液经过分离纯化后，采用液相色谱二极管阵列检测器（HPLC-DAD）、高分辨质谱（HRMS）、核磁共振谱（NMR）进行结构确证。结果：证明该定位溶液中确实得到了双纳美芬。结论：此方法可用于盐酸纳美芬有关物质检查时双纳美芬杂质的准确定位。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish a preparation method of bisanalmefene positioning solution. Methods: Bisanalmefene positioning solution for detection was prepared by heating nalmefene hydrochloride solution with ferric chloride and hydrochloric acid. Bisanalmefene was separated and confirmed by HPLC-DAD, HRMS and NMR. Results: The structure in the position solution was confirmed to be bisanalmefene. Conclusion: The method can be used to locate bisanalmefene in nalmefene impurity detection.
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