摘要
目的:建立以高效液相色谱法检测盐酸奈福泮注射液中的有关物质的方法。方法:色谱柱为C18柱,流动相为甲醇-水-三乙胺(50∶50∶0.5),流速为1.0 mL.min-1,柱温为30℃,检测波长267 nm。结果:各项专属性试验中,盐酸奈福泮主峰与其它杂质峰均分离良好;3批样品中杂质峰面积之和均未超过对照液主峰面积的1%。结论:该法简单准确。
Objective：To establish a HPLC method for the determination of the related substances in nefopan hydrochloride injection. Methods： The determination was performed with C18 column as the chromatographic column. The mobile phase was consisted of methanol-water-triethylamine （50： 50： 0.5,v ：v ：v）with a flow rate at 1.0 mL·min^-1 The column temperature was 30℃ and the detection wavelength was 267nm. Results： All the chief peaks of nefopan hydrochloride and those of their related substances could be well isolated in all the specificity tests. The total peak area of the impurity of all the 3 batches of samples were no more than 1% of the chief peak area. Conclusion： This method is simple, accurate and reproducible.
出处
《药学与临床研究》
2007年第4期339-340,共2页
Pharmaceutical and Clinical Research
