HPLC测定拉科酰胺原料药的含量及其有关物质

目的：建立高效液相色谱法（HPLC）测定拉科酰胺原料药的含量及其有关物质的方法。方法：采用高效液相色谱法（HPLC）,以十八烷基硅烷键合相硅胶为固定相（4.6 mm×250 mm,5μm）,色谱纯甲醇为流动相,检测波长210nm,流速为1.0 mL/min,色谱柱柱温35℃,测定拉科酰胺原料药的含量及其有关物质。结果：拉科酰胺进样量在1.0～200.0μg/mL范围内,与峰面积呈良好的线性关系,其回归方程为Y=7.995 2 c＋9.993 6（r=0.999 9）。平均回收率为100.2%（RSD为0.75%,n=6）。结论：该方法操作简单、方便、准确、重复性好,用于控制拉科酰胺的含量可信度高。

Detected by HPLC Deportivo Lacosamide Content and Related Substances

Objective：To estabLish a method for the determination of lacosamide by HPLC.Methods：The condition of HPLC was KromasiL C18 column（octadecylsiLan reversed bonded phase,4.6 mm×250 mm,5 μm）,mobile phase of chromatographic purity methanol and UV dector at 210 nm.The flow rate was 1.0 mL·min-1 and the column temperature was 35℃.Results：The method proved to be linear in the range at 1.0～200.0 μg/mL of lacosamide with correLation coefficient of 0.999 9.The linear formula was Y=7.995 2c＋9.993 6（r=0.999 9）.The average recovery and recision were 100.2% and RSD=0.75%（n=6）.Conclusions：The method is simple,accurate,and can be a effective method to control the quality of the preparation.