【摘要】 目的建立了N-[2-(5-甲氧基-1H-吲哚-3-)乙基]己酰胺(MLT-5)含量测定和有关物质检查的方法。方法采用Zorbax300SBC18(4·6mm×250mm,5μm)色谱柱,流动相为甲醇-水(55∶45),流速1·0mL·min-1,检测波长277nm。结果在所选定的液相色谱条件下,有关物质与主药完全分离,MLT-5在0·05~40mg·L-1(r=0·9997)内线性关系良好,最低检测限为0·4ng。检测了3批样品,主峰含量均在99·0%以上,有关物质在1%以内。结论此法简便、灵敏、准确,可用于MLT-5的含量测定和有关物质检查。更多还原

【Abstract】 OBJECTIVE To establish a HPLC method for the determination of N-[2-(5-methoxy-1H-indol-3-)ethyl]heximide(MLT-5) and its related substances. METHODS A HPLC method was used with a Zorbax 300 SB C_ 18 (4.6 mm×250 mm,5 μm) column and a mobile phase of methanol-water(55∶45). The flow rate was 1.0 mL·min~ -1 ,and the wavelength was set at 277 nm.RESULTS MLT-5 and its related substances were completely separated with a linear range of 0.05～40 mg·L~ -1 (r=0.999 7).The detection limit of 0.4 ng was obtained. The MLT-5 contents of three batches were over 99.0% with related substances less than 1% and its related substances. CONCLUSION The method is simple,sensitive and accurate,which can be used to determine MLT-5.更多还原