Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

A kind of detection method of isomer impurity in vincamine

A detection method, the technology of vincamine, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of complex detection methods, limited accuracy and sensitivity, and achieve high sensitivity, high accuracy, and improved detection efficiency.

Active Publication Date: 2022-06-17
开封康诺药业有限公司 +1
View PDF0 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing technical detection methods for vincamine isomer impurity are relatively complicated, and the accuracy and sensitivity of this impurity detection are limited

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A kind of detection method of isomer impurity in vincamine
  • A kind of detection method of isomer impurity in vincamine
  • A kind of detection method of isomer impurity in vincamine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Sample testing:

[0035] High performance liquid chromatography was used for detection, and the chromatographic conditions were as follows:

[0036] Flow rate: 0.8ml / min;

[0037] Detection wavelength: 227nm;

[0038] Column temperature: 25℃;

[0039] Mobile phase: Mix borax-boric acid buffer with pH of 9 and concentration of 0.02mol / L and acetonitrile in a volume ratio of 67:33 to obtain a mobile phase;

[0040] Chromatographic column: The chromatographic column is a CHIRALPAK OD-RH chiral column from Daicel Co., Ltd., with a length of 150 mm, a diameter of 4.6 mm, and a particle size of the filler of 5 μm.

[0041] The solution is prepared as follows:

[0042] Solvent preparation: The pH is 9, the concentration is 0.02mol / L disodium hydrogen phosphate-sodium hydroxide buffer and acetonitrile are mixed uniformly in a volume ratio of 67:33 to obtain a blank solvent;

[0043] Preparation of vincamine test solution: take 10mg vincamine test solution, add 10mL of acet...

Embodiment 2

[0048] Methodological validation:

[0049] According to the chromatographic conditions of Example 1, the specificity, stability, linearity, detection limit and quantification limit, precision and accuracy are respectively verified by methodology, and the results are as follows:

[0050] (1) Exclusivity

[0051] The solution is prepared as follows:

[0052] Solvent preparation: The pH is 9, the concentration is 0.02mol / L disodium hydrogen phosphate-sodium hydroxide buffer and acetonitrile are mixed uniformly in a volume ratio of 67:33 to obtain a blank solvent;

[0053] Preparation of vincamine test solution: take 10mg vincamine test solution, add 10mL of acetonitrile for ultrasonic dissolution, dilute with solvent, shake well to obtain vincamine test solution with a concentration of 500μg / mL;

[0054] Preparation of vincamine reference solution: take 10 mg of vincamine reference solution, add 10 mL of acetonitrile to dissolve by ultrasonic, dilute with solvent, and shake wel...

Embodiment 3

[0183] Sample testing:

[0184] High performance liquid chromatography was used for detection, and the chromatographic conditions were as follows:

[0185] Flow rate: 1.2ml / min;

[0186] Detection wavelength: 240nm;

[0187] Column temperature: 28℃;

[0188] Mobile phase: Mix borax-boric acid buffer solution with pH of 8.9 and concentration of 0.04mol / L and acetonitrile in a volume ratio of 70:40 to obtain mobile phase;

[0189] Chromatographic column: The chromatographic column is a CHIRALPAK OD-RH chiral column from Daicel Co., Ltd., with a length of 250 mm, a diameter of 4.6 mm, and a particle size of the filler of 5 μm.

[0190] The solution is prepared as follows:

[0191] Solvent preparation: mix evenly with pH 8.9 and concentration 0.03mol / L disodium hydrogen phosphate-sodium hydroxide buffer and acetonitrile in a volume ratio of 70:40 to obtain a blank solvent;

[0192] Preparation of vincamine test solution: take 10mg vincamine test solution, add 10mL of acetonit...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
lengthaaaaaaaaaa
diameteraaaaaaaaaa
particle sizeaaaaaaaaaa
Login to View More

Abstract

The invention discloses a method for detecting isomer impurities in vincamine, which uses high-performance liquid chromatography for detection, uses a CHIRALCEL OD-RH chiral chromatographic column as a chromatographic column, and uses a mixed solution of borax-boric acid buffer and acetonitrile Carry out isocratic elution for mobile phase, record chromatogram, calculate the content of impurity A in vincamine according to the peak area in chromatogram. The method of the invention can quantitatively determine the content of the isomer impurity A in the vincamine raw material, has the advantages of high accuracy and high sensitivity, and is beneficial to the quality control of the vincamine raw material.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting isomer impurities in vincamine. Background technique [0002] Vincamine is a cerebral vasodilator that can be used to treat cerebral arteriosclerosis, cerebral infarction, etc. Also, vincamine is a key starting material for vinpocetine. In the raw materials of vincamine, the structural formula is The chemical formula is C 21 H 26 N 2 O 3 , an isomer impurity with a molecular weight of 354.44. The detection result of this impurity is not only an important indicator for judging the quality level of vincamine, but also the key to the quality control of vinpocetine pharmaceutical preparations. However, the existing vincamine isomer impurity detection method is relatively complicated, and the accuracy and sensitivity of the impurity detection are limited. SUMMARY OF THE INVENTION [0003] Based on the technical problems existing in the backgroun...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34
CPCG01N30/02G01N30/06G01N30/34G01N2030/047
Inventor 王伟周多玲陶杰杨甲旺林子荣
Owner 开封康诺药业有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com