HPLC法测定N-（2-羟乙基）烟酰胺中的有关物质

摘要

Objective To establish an HPLC method for detection of N-(2-hydroxyethyl) nicotinamide related substances. Methods The analytical column was C18 column (4.0mm×25cm, 5μm); The mobile phase was water:THF∶triethylamine∶trifluoroacetic acid=982∶10∶5∶3;The wavelength was 254nm;The flow rate was 1.0 mL/min. Results A satisfactory separation condition for the five related impurities, the impurities standard curve was good linear in the range of 1.0-20μg/mL . Conclusion The method is sensitive and accurate and it can be used to determine the relateted substances of nicorandil.%目的：建立N-（2-羟乙基）烟酰胺中有关物质的测定方法。方法碳十八烷键合硅胶（5μm）填充4.0mm×25cm不锈钢柱；流动相为水∶四氢呋喃∶三乙胺∶三氟乙酸（982∶10∶5∶3）；检测波长：266nm；流速：1.0mL/min。结果N-（2-羟乙基）烟酰胺与主要杂质能得到有效分离，各杂质在1.0～20μg/mL范围内呈良好线性关系。结论本测定方法灵敏度高，准确可靠，可以控制N-（2-羟乙基）烟酰胺中有关物质的含量。