论文部分内容阅读
讨论了硝酸甘油片有关物质中二硝基甘油的测定方法,对中国药典的色谱条件做了适当的修改,避免出现误判。采用HPLC法,使用Zorbax SB-C18色谱柱(4.6 mm×250 mm,5 m),以乙腈-水(40︰60)为流动相,流速0.3 ml/min,检测波长215 nm。在本色谱条件下,硝酸甘油有关物质中二硝基甘油的两个同分异构体1,2-O-二硝基甘油和1,3-O-二硝基甘油分离完全。如用150 mm色谱柱,或流速加快,则两个异构体不能良好分离。
The method for the determination of dinitro-glycerol in nitroglycerin-related substances was discussed. The chromatographic conditions of the Chinese Pharmacopoeia were modified appropriately to avoid misjudgment. The mobile phase was acetonitrile-water (40:60) at a flow rate of 0.3 ml / min using a Zorbax SB-C18 column (4.6 mm × 250 mm, 5 μm) with a detection wavelength of 215 nm. Under the chromatographic conditions, the two isomers of 1,2-O-dinitroglycerol and 1,3-O-dinitroglycerol of dinitroglycerol in nitroglycerin-related substances are completely separated. If using a 150 mm column or if the flow rate is increased, the two isomers do not separate well.