Check patentability & draft patents in minutes with Patsnap Eureka AI!

Method for determining related substances of thioctic acid injection by high performance liquid chromatography

A technology for high performance liquid chromatography and related substances, which is applied in the field of high performance liquid chromatography for the determination of related substances in lipoic acid injection, can solve the problems of no public detection method, etc., achieves convenience of quality inspection and monitoring, and is conducive to safe popularization and application , highly reproducible effect

Active Publication Date: 2019-08-13
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
View PDF5 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no disclosed detection method for the above-mentioned impurities (especially lipoic acid amide monosubstituted and double-substituted impurities), so it is necessary to provide a method for related substances of lipoic acid injection

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
  • Method for determining related substances of thioctic acid injection by high performance liquid chromatography
  • Method for determining related substances of thioctic acid injection by high performance liquid chromatography
  • Method for determining related substances of thioctic acid injection by high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] A method for the determination of related substances in lipoic acid injection by high performance liquid chromatography, using the following conditions for determination:

[0052] Chromatographic column: use octadecylsilane bonded silica gel as filler;

[0053] Mobile phase A: Potassium dihydrogen phosphate A solution with a concentration of 0.005mol / L and a pH value of 3.1;

[0054] Mobile phase B: a mixed solution of methanol and acetonitrile with a volume ratio of 42:8;

[0055] Column temperature: 30°C;

[0056] Detection wavelength: 215nm;

[0057] Flow rate: 1.0mL / min;

[0058] Adopt gradient elution, take the total volume of described mobile phase as 100%,

[0059]At 0 to 40 minutes, the volume of the mobile phase A decreases from 80% to 40%, and the volume of the mobile phase B increases from 20% to 60%;

[0060] At 40 to 70 minutes, the volume of the mobile phase A is 40%, and the volume of the mobile phase B is 60%;

[0061] At 70-72 minutes, the volume ...

experiment example 1

[0065] Experimental Example 1 System Suitability Test

[0066] Diluent: 0.05mol / L potassium dihydrogen phosphate solution-ethanol (40:60), adjust the pH value to 3.5 with phosphoric acid.

[0067] Blank excipient solution: Accurately weigh about 33mg of ethylenediamine, put it in a 5mL brown measuring bottle, dilute with water to the mark, shake well, take 3mL in a 50mL brown measuring bottle, dilute with solvent to the mark, shake well, and use it as the blank excipient solution.

[0068] Preparation of the mixed control solution: take impurities A, C, D, oxidized impurities, lipoic acid amide mono-substituted impurities, lipoic acid amide double-substituted impurities, lipoic acid ethyl ester and 6,8-dichlorooctanoic acid ethyl ester and lipoic acid in an appropriate amount, Add diluent (the diluent is a mixture of potassium dihydrogen phosphate B solution and ethanol, the volume ratio is 40:60 (weigh 6.80g of potassium dihydrogen phosphate, add water to dissolve and dilute ...

experiment example 2

[0079] Experimental example 2 linearity and range test

[0080] Stock solution of each impurity solution: Accurately weigh 3 mg each of impurities A, C, D, lipoic acid amide mono-substituted impurities, lipoic acid amide double-substituted impurities, ethyl lipoic acid and ethyl 6,8-dichlorooctanoate, and place in different In a 10mL measuring bottle, put 75mg of oxidized impurities in a 50mL measuring bottle, put 3mg of double-substituted impurities in a 100mL measuring bottle, add diluent to dilute to the mark, shake well, and use it as the stock solution of each impurity solution respectively.

[0081] Lipoic acid reference substance stock solution: Accurately weigh 35mg of lipoic acid reference substance, put it in a 50mL measuring bottle, add diluent to dilute to the mark, shake well, and get it.

[0082] Linear solution: Accurately measure 1 mL of lipoic acid reference substance stock solution and each impurity stock solution in the same 10 mL measuring bottle, add dilue...

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
wavelengthaaaaaaaaaa
Login to View More

Abstract

The invention relates to the field of drug detection, in particular to a method for determining related substances of thioctic acid injection by high performance liquid chromatography. The mobile phases of the method comprise a mobile phase A which is a mono potassium phosphate A solution and a mobile phase B which is a mixed solution of methanol and acetonitrile. By using a specific gradient elution method, related substances in thioctic acid injection (including thioctic acid and at least 11 common impurities) can be separated in a high performance liquid chromatogram. And the optimization of conditions further improves the detection sensitivity and content accuracy of each component. The method has good specificity, fast analysis speed and high reproducibility, is convenient for qualitydetection and monitoring of thioctic acid injection, and is beneficial to the safe promotion and application of thioctic acid.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for determining related substances in lipoic acid injection by high performance liquid chromatography. Background technique [0002] Alpha Lipoic Acid (Alpha Lipoic Acid) is a coenzyme present in mitochondria, which has a high free radical reaction ability, can eliminate free radicals in the body, and has anti-inflammatory and anti-aging effects. It is currently widely used in the prevention and treatment of heart disease, diabetes, liver disease and senile dementia. In 2000, Alpha Lipoic Acid Injection (Aolibao) of German Stadt Company was imported into the market in China. [0003] Lipoic acid samples are unstable and prone to impurities, mainly including oxidative impurities, 6,8-cyclotrilipoic acid, dihydrolipoic acid, etc. The auxiliary material used in the prescription process of lipoic acid injection is ethylenediamine. Lipoic acid and the auxiliary material ethyle...

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 Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 宋更申魏兴张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
Features
  • R&D
  • Intellectual Property
  • Life Sciences
  • Materials
  • Tech Scout
Why Patsnap Eureka
  • Unparalleled Data Quality
  • Higher Quality Content
  • 60% Fewer Hallucinations
Social media
Patsnap Eureka Blog
Learn More

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

© 2025 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com