Method for detecting related substances of vincamine acid and apovincamine acid in injection

Abstract

The invention provides a method for detecting related substances of vincamine acid and apovincamine acid in an injection, which adopts high performance liquid chromatography to quantitatively identify impurities of vincamine acid and apovincamine acid in a vinpocetine injection; and the chromatographic conditions are as follows: a filler of a chromatographic column is cyanosilane bonded silica gel, the flow rate is 0.5-0.7 mL.min<-1 >, the column temperature is 30-34 DEG C, and a 0.1 mol / L-0. 25mol / L triethylamine solution and ethanol in a volume ratio of (30-65): (65-70) are used as mobile phases. According to the method disclosed by the invention, the contents of the impurity vincamine acid and the impurity apovincamine acid in the vinpocetine injection are determined by utilizing a high performance liquid chromatography, the method has the advantages of good separation effect, sensitivity, accuracy and the like, and the quality stability, uniformity and curative effect of the product are ensured; the method disclosed by the invention is simple, strong in specificity and good in reproducibility, the quality and the curative effect of the vinpocetine injection are effectively guaranteed, and the method has very strong practicability.

Description

technical field [0001] The invention relates to the field of medicine quality detection, in particular to a method for detecting related substances vincine and apovincine in an injection. Background technique [0002] Vinpocetine (VIN for short), chemical name: ethyl(13aS,13bS)-13a-ethyl-2,3,5,6,13a,13b-hexahydro-1H-indole[3,2 ,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylic acid. [0003] This product was first developed and marketed by the Hungarian drug company Cedeon Richter in 1978. It is mainly used for the treatment of cardiovascular and cerebrovascular diseases, ischemic hypertensive encephalopathy, cerebral arteriosclerosis, cerebral ischemia, intermittent cerebral blood flow insufficiency, cerebrovascular Convulsions, cerebral thrombosis, brain diseases caused by aging, etc. [0004] The chemical structure of this product is: [0005] [0006] With reference to the relevant varieties in the Chinese Pharmacopoeia 2015 edition, and with reference to the a...

AI Technical Summary

Problems solved by technology

[0006] With reference to the relevant varieties in the Chinese Pharmacopoeia 2015 edition, and with reference to the above quality standards, high performance liquid chromatography was also used, with isocratic elution, and the known impurities were calculated according to the peak area by the external standard method. The unknown impurity content of this product is determined by the composition self-comparison method. At the same time, due to the increase in the research on the synthetic starting materials, synthetic intermediates and related impurities found, the relevant substances are re-tested on the basis of the detection methods of the relevant substances in the original application standards. The methodological research of related substances and methodological research found that the synthetic intermediate of vinpocetine, vinblastine, and the impurity, apovincine, cannot be separated in the original detection method of related substances, so a detection method is urgently needed to solve the above problems

Images