摘要
目的建立草酸萘呋胺酯包衣微丸的有关物质测定方法。方法采用高效液相色谱法测定,色谱柱:Hy-persilBDSC6H5(4.6mm×250mm,5μm);柱温:25℃;流动相:0.05mol/L乙酸钠(用磷酸调节pH=4.0)-乙腈(40∶60),流速:1.0mL/min;检测波长:283nm;进样量:20μL。结果草酸萘呋胺酯与杂质能完全分离,草酸萘呋胺酯最小检测限为3ng。结论该方法灵敏、专属,可用于草酸萘呋胺酯包衣微丸有关物质的检查。
Objective To establish a method for the determination of related substance in naflidrofuryl oxalate coated pellets. Methods HPLC method was used, the analytical column was Hypersil BDS C6H5 （4.6 mmx250 mm,5μm） with column temperature at 25℃, and the mobile phase was composed of 0.05 mol/L sodium acetate （adjusted to pH=4.0 with orthophosphoric acid）-acetonitrile （40：60） with flow rate at 1 mL/min. The detection wavelength was at 283 nm and the sample size was 20 IxL. Results Naftidrofuryl oxalate could be separated from impurity completely and the detec- tion limit was 3 ng. Conclusion The method is exclusive, sensitive and reliable, and it is suitable for the determination of related substance in naftidrofuryl oxalate coated pellets.
出处
《中国当代医药》
2013年第4期71-72,共2页
China Modern Medicine
关键词
HPLC法
草酸萘呋胺酯
微丸
有关物质
High performance liquid chromatography
Naftidrofuryl oxalate
Pellets
Related substance
