HPLC测定美乐托宁中的有关物质  

Determination of the related substances in Melatonin by HPLC

作　　者：严相平[1] 殷婷婷[1,2] 冷柏榕[1] 

机构地区：[1]南京工业大学江苏省药物研究所,江苏南京210009 [2]南京工业大学药学院,江苏南京211816

出　　处：《华西药学杂志》2014年第2期210-211,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC测定美乐托宁的有关物质。方法采用CosmosilC18色谱柱（250mm×4．6mm．5μm），流动相为甲醇-0．01mol·L-1磷酸二氢钾溶液（40：60），流速1．0mL·min-1，检测波长为220nm。结果主成分与有关物质可完全分离，0．202-1．212μg·mL-1 5-甲氧基色胺杂质与峰面积线性关系良好。5-甲氧基色胺加样回收率为99．96％，RSD=0．82％（n=9）。结论所用方法准确、简便、快速，适用于美乐托宁有关物质的检查。OBJECTIVE To develop an HPLC method to determine the related substances of Melatonin. METHODS An HPLC meth- od was adopted with Cosmosil - C18 column （250 mm ×4.6 mm, 5 μm）. The mobile phase was consisted of methanol - 0.01 mol. L-1 potassium dihydrogen phosphate（40 ： 60） with a flow rate of 1.0 mL.min-l and the detective wavelength was at 220 nm. RESULTS Principal components and related substances could be completely separated. The calibration curve was linear（ r = 0. 9996）within the range of 0.804 - 1. 205 μg.mL- 1 for impurity of 5 - methoxytryptamine. The average recovery of 5 - methoxytryptamine was 99.96%, RSD = 0. 82% （n = 9）. CONCLUSION The method is accurate, simple,rapid, and suitable for anlaysis of related substances in Melatonin.

关 键 词：美乐托宁 有关物质 高效液相色谱法 5-甲氧基色胺 

分 类 号：R917[医药卫生—药物分析学]