RRLC-QTOF鉴定拉科酰胺的未知杂质

RRLC-QTOF Applied to the Impurities Profile of Lacosamide

摘要: 目的通过快速液相-四极杆飞行时间串联质谱(RRLC-QTOF)法分离、鉴定拉科酰胺粗品中4个未知杂质。方法采用美国Agilent RRLC快速液相色谱系统和6530型四极杆-飞行时间串联质谱仪，色谱柱为XDB-C₁₈(150 mm×4.6 mm，5 μm)，流动相为醋酸铵-水溶液(甲酸调节pH至4.5)和乙腈，梯度洗脱，流速为1.0 mL·min^-1，采用柱后分流，其中质谱仪进样流速为0.3 mL·min^-1。结果结合高分辨质量数和二级质谱碎片推测得到了拉科酰胺粗品中4个可能的杂质结构。结论本研究为拉科酰胺的质量研究提供参考。

Abstract: OBJECTIVE To study the impurities profile of lacosamide with RRLC-QTOF method. METHODS The high performance liquid chromatography and quadrupole-flight time tandem mass spectrum (RRLC-QTOF) were used to analyze lacosamide. The column was XDB-C₁₈(150 mm×4.6 mm, 5 μm). Acetonitrile and ammonium acetate buffer (pH4.5) were used as mobile phase with gradient elution. The total flow was 1 mL·min^-1 and 0.3 mL·min^-1 flowing into mass spectrum by a joint. RESULTS Combined the high resolution mass and MS² fragment ions, the possible structure of four impurities in lacosamide were infered. CONCLUSION It is good reference for the research of the impurities profile in lacosamide.