CAJ | 학술논문

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。
목적：건립N-（2-간을기）연선알중유관물질적측정방법。방법탄십팔완건합규효（5μm）전충4.0mm×25cm불수강주；류동상위수∶사경부남∶삼을알∶삼불을산（982∶10∶5∶3）；검측파장：266nm；류속：1.0mL/min。결과N-（2-간을기）연선알여주요잡질능득도유효분리，각잡질재1.0～20μg/mL범위내정량호선성관계。결론본측정방법령민도고，준학가고，가이공제N-（2-간을기）연선알중유관물질적함량。
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.