A kind of detection method of related substances vincristine and apo-vinblastine in injection

A technology of apvincine and vincine, which is applied in the field of detection of related substances vincine and apavincine in injections, and can solve the problem of inability to separate and increase the impurities related to the synthesis of starting materials and synthetic intermediates Research and other issues to achieve strong specificity, ensure stable quality, uniformity, curative effect, and good separation effect

Active Publication Date: 2022-02-22
HAINAN HULUWA PHARMA GRP CO LTD
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  • Application Information

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

Method used

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  • A kind of detection method of related substances vincristine and apo-vinblastine in injection
  • A kind of detection method of related substances vincristine and apo-vinblastine in injection
  • A kind of detection method of related substances vincristine and apo-vinblastine in injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] (1) Determination of the content of impurity vincine and impurity apovincine

[0035] (1) Precisely measure an appropriate amount of Vinpocetine injection, make a solution containing about 1.0 mg of Vinpocetine in every 1ml with mobile phase quantitative dilution, as the test solution;

[0036] (2) Get the appropriate amount of impurity vincine and impurity apvincine reference substance, accurately weighed, add mobile phase to dissolve and quantitatively dilute to make each 1ml containing approximately impurity vincine, impurity apvincine 2 μg of mixed solution, as impurity reference substance solution;

[0037] (3) Get Vinpocetine reference substance 10mg, put in 10ml measuring bottle, dissolve and dilute to scale with impurity reference substance solution, shake up, as system suitability test solution;

[0038] (4) Take 20 μl of the system suitability test solution, inject it into the liquid chromatograph, and record the chromatogram. The order of the peaks is impuri...

Embodiment 2

[0050] Example 2 - The difference between this example and Example 1 is that a 0.25 mol / L triethylamine solution and ethanol with a volume ratio of 30:70 are used as mobile phases. The results showed that the peak shapes of vinpocetine, vinblastine and apovincine were good.

Embodiment 3

[0051] Example 3 - The difference between this example and Example 1 is that 0.1 mol / L triethylamine solution and ethanol with a volume ratio of 1:1 are used as the mobile phase. The results showed that the peak shapes of vinpocetine, vinblastine and apovincine were good.

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Abstract

The invention provides a method for detecting related substances vinblastine and apovincine in an injection, which uses high performance liquid chromatography to quantitatively identify impurity vinblastine and impurity apovincine in vinpocetine injection , the chromatographic conditions are: the filler of the chromatographic column is cyanosilane bonded silica gel, the flow rate is 0.5-0.7mL min-1, the column temperature is 30-34°C, and the volume ratio is 30-65:65-70 of 0.1 mol / L~0.25mol / L triethylamine solution and ethanol are mobile phases. The present invention uses high performance liquid chromatography to measure the content of impurity vinblastine and impurity apovincine in vinpocetine injection. The method has the advantages of good separation effect, sensitivity and accuracy, and ensures stable and uniform quality of the product. Sexuality and curative effect; The method of the present invention is simple, specificity is strong, reproducibility is good, has guaranteed the quality and curative effect of vinpocetine injection effectively, 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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/047
Inventor 刘景萍刘全国陈克领麦发任吴育强郑国菊王家李党
Owner HAINAN HULUWA PHARMA GRP CO LTD
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