HPLC法测定拉莫三嗪片的含量

Determination of Lamotrigine tablets by HPLC

目的:建立以高效液相色谱法测定拉莫三嗪片含量的方法。方法:色谱柱为Welch UltusilTM C18(250×4.6m,5μm);流动相为甲醇-0.5%三乙胺溶液(用磷酸调解pH值至4.0)(36:64);流速为0.8ml·min-1;检测波长265nm;柱温为40℃,进样量为20μl。结果:拉莫三嗪在0.016～0.061mg·ml-1范围内与峰面积呈良好的线性关系,r=0.9997,加样回收率为98.2%～101.0%。结论:该方法准确、可靠、重复性好,可作为拉莫三嗪片的含量测定方法。

Objective：To establish the HPLC method for the determination of Lamotrigine tablet content. Methods： The analysis was carried on a columu of Welch Ultusil^TM C18 （250×4.6m,5μm）whth a mobile phase of methanol-0,5% triethylamine solution（phosphoric acid R adjust pH value to 4.0）（36：64）at the flow rate of 0.8ml·min^-1.The detection wavelength was 265um. Results： The linearity was obtained over the range of 0.016-0.061mg· ml^-1 （r=0.9997）. The average recoveries of lamotrigine were all in 98.2%-101.0%, and the RSDs were 0.9%.Conclusion：The method is simple,accurate and rapid.It may be suitable for the usual quality control of Lamotrigine tablets.