The Composition Analysis And Related Substances Research On Vinpocetine Injection

Objective:This topic is a research about the composition and related substance of vinpocetine injection with high performance liquid chromatography,gas chromatography,ultraviolet-visible spectrophotometry etc.In order to study the original source of the ingredients and the categories of impurities,provide scientific and reasonable data for the evaluation of generic drug,we did the following research:(1)The assay of vinpocetine:Liquid chromatography.Column:Waters XSELECT CSH C18(4.6×250mm,5?m);Mobile phese:acetonitrile and annonium acetate solution(40:60);Dtection:spectrophotommmeter at 280nm;Flow rate:1.0ml/min;Temperature;25?.The results show that this method has a strong specificity and this method can be used for assay of vinpocetine injection.(2)The assay of Vitamin C:Liquid chromatography.Column:Waters Spherisorb NH2(4.6×250mm,5?m);Mobile phese:acetonitrile and Monopotassium phosphate solution(30:70);Dtection:spectrophotommmeter at 265nm;Flow rate:1.0ml/min;Temperature:30?.The results show that this method has a strong specificity and this method can be used for assay of Vitamin C.(3)The assay of sorbitol:Liquid chromatography.Column:Waters Spherisorb NH2(4.6x250mm,5?m);Mobile phese:acetonitrile and water(20:80);Dtection:refractive index detector;Flow rate:1.0ml/min;Temperature:35?.The results show that this method has a strong specificity and this method can be used for assay ofsorbitol.(4)The assay of phenylcarbinol:Gas chromatography.Column:Agilent DB-WAX(30m×0.25mm,0.25?m);Dtection:Flame Ionization Detector;The results show that this method has a strong specificity and this method can be used for assay of phenylcarbinol.(5)The assay of Sodium Metabisulphite:ultraviolet-visible spectrophotometry.The test sample solution was diluted by Fuchsine solution?Formaldehyde solution and water,Test the absorbance at the wavelength of 556 nm;The results show that this method has a strong specificity and this method can be used for assay of Sodium Metabisulphite.(6)The analysis of related substance of vinpocetine injection:Liquid chromatography.Column:Waters XSELECT CSH C18(4.6×250mm,5?m);Mobile phese:acetonitrile and annonium acetate solution;Dtection:spectrophotommmeter at 280nm;Flow rate:l.Oml/min;Temperature:25 C.The results show that this method has a strong specificity and this method can be used for analysis of related substance of vinpocetine injection.And other,we tested the impurities by LC-MS,researched the sources and structures of the impurities.In the end,we researched the stability of vinpocetine injection and the potential genotoxic impurities in vinpocetine injection.