HPGC测定盐酸美金刚有关物质的方法学研究

Study on the Methodology of Determination of Memantine Hydrochloride Related Substances by HPGC

建立了采用高效气相色谱(HPGC)法测定N-甲基-D-天冬氨酸(NMDA)受体拮抗药盐酸美金刚有关物质的方法。使用Agilent DB-5(50 m×0.32 mm×0.52μm)或效能相当的色谱柱,以氢气为燃气、空气为助燃气、氦气为载气,恒流速为4.0 mL/min,分流比为20∶1,进样口温度为220℃,检测器温度为300℃。在上述色谱条件下,盐酸美金刚与各杂质分离效果良好(R>l.5),检测限为1.0621 mg/L,定量限为2.1242 mg/L,在2124~12745 mg/L范围内,质量浓度与峰面积成线性关系(R^(2)=0.9925),且辅料对主药的测定无干扰。该方法简单快速、准确稳定,且专属性良好,可用于盐酸美金刚片有关物质的测定。

A high-performance gas chromatography(HPGC)method was established for the determination of N-methyl-D-aspartate(NMDA)receptor antagonist memantine hydrochloride related substances.It uses Agilent DB-5(50 m×0.32 mm×0.52μm)or chromatographic column with equivalent performance,taking hydrogen as fuel gas,air as auxiliary fuel gas,helium as carrier gas with constant flow of 4.0 mL/min and the split ratio of 20∶1.The temperature of the inlet is 220℃,the temperature of the detector is 300℃.Under above chromatographic conditions,the separation effect of memantine hydrochloride from each impurity is good(R>1.5),the detection limit is 1.0621 mg/L,the quantification limit is 2.1242 mg/L.In the range of 0.002124-0.012745 mg/L,the mass concentration has a linear relationship with the peak area(R^(2)=0.9925),and the excipients do not interfere with the determination of the main drug.The method is simple,rapid,accurate and stable,and has good specificity,and it can be used for the determination of related substances in memantine hydrochloride tablets.