柱前衍生HPLC-UV法测定盐酸美金刚胺中主药及有关物质的含量

目的:建立以柱前衍生高效液相色谱-紫外分光光度法测定盐酸美金刚胺中主药及有关物质含量的方法。方法:色谱柱为Hypersil ODS2 C18,衍生试剂为对硝基苯甲酰氯,流动相为乙腈-水(85∶15),流速为1.0mL·min-1,检测波长为220nm,柱温为室温,进样量为5μL。结果:盐酸美金刚胺检测浓度的线性范围为0.2～1.0mg·mL-1(r=0.9993),平均加样回收率为98.5%,RSD=1.42%,最小检测限为3.0ng(S/N≥3),平均有关物质含量均小于0.16%。结论:本方法操作简便,结果准确可靠、重现性好,可用于该制剂的含量测定。

Determination of Memantine Hydrochloride and Its Related Substances by HPLC-UV Method with Pre-column Derivatization

OBJECTIVE： To establish the HPLC-UV method with pre-colunm derivatization for determination of memantine hydrochloride and its related substances. METHODS：The separation was detected on Hypersil ODS2 C18 column with flow rate of 1.0 mL.min^-1 and detection wavelength of 220 nm. Mobile phase consisted of acetonitrile-water （85 ： 15）; column temperature was set at room temperature and injection volume was 5 uL. RESULTS：Excellent linear correlation was showed within the range of 0.2-1.0 mg·mL^-1 （r=0.999 3） with recovery of 98.5% （RSD=1.42%） ; the minimum detection limit was 3.0 ng（S/N≥3）. The contents of related substances were all less than 0.16%. CONCLUSION： The method is simple, accurate and reproducible and it is applicable for content determination of the preparation.