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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。
OBJECTIVE: To establish a dual nalmefene implants positioning solution for the control of nalmefene in nalmefene hydrochloride starting materials and preparations. METHODS: The nalmefene hydrochloride reference substance was catalyzed by ferric chloride in acidic condition and heated in water bath to obtain a bunamentine localization solution. The localization solution was separated and purified and analyzed by liquid chromatography with diode array detector (HPLC- DAD, HRMS and NMR. Results: This proved that the positioning solution did get double nalmefene. Conclusion: This method can be used for the accurate localization of bis-nalmefene impurity in nalmefene hydrochloride related substances.