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Analysis and detection method of glycocholic acid polyethylene glycol derivatives

A polyethylene glycol and detection method technology, applied in the field of high performance liquid chromatography analysis, can solve problems such as large detection error, baseline jump, chromatographic column damage, etc., and achieve the effects of stable baseline, good protection and life, and good linear relationship

Active Publication Date: 2022-01-04
长沙创新药物工业技术研究院有限公司
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  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In traditional technology, PEG derivatives are generally analyzed and detected by LCMS method, which has a baseline jump and a large detection error
And in order to improve the peak shape, it is usually necessary to add a certain proportion of acid to the mobile phase, resulting in damage to the chromatographic column

Method used

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  • Analysis and detection method of glycocholic acid polyethylene glycol derivatives
  • Analysis and detection method of glycocholic acid polyethylene glycol derivatives
  • Analysis and detection method of glycocholic acid polyethylene glycol derivatives

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Instruments and equipment: ELSD detector waters 2695

[0033] Chromatographic conditions: Chromatographic column: 5 TC C18(2) 4.6x150mm 5μm

[0034] Flow rate: 0.8ml / min Column temperature: 30℃

[0035] Drift tube temperature: 70°C Air pressure: 30psi Atomization method: 60% heating (30°C)

[0036] Need testing solution: take need testing 10mg, put in 10ml measuring bottle, dissolve with acetonitrile and dilute to the mark, shake well, make every 1mg / ml solution, as need testing solution

[0037] Blank solution: Acetonitrile

[0038] Injection volume: 10μl

[0039] Sample analysis: each of the blank solution and the test solution was injected into 1 needle.

[0040] Gradient elution program:

[0041] Mobile phase: A: pure water, C: acetonitrile

[0042] time (min) A% C% 0 85 15 1 85 15 15 20 80 25 20 80

[0043] Calculate the purity and simple impurity with the area normalization method, the result is as follows figure 1 s...

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Abstract

The invention discloses an analysis and detection method of glycocholic acid polyethylene glycol derivatives. The analysis and detection method is carried out by using LC-ELSD liquid chromatography. It is separated from its impurities, and detected by LC-ELSD, with a stable baseline, good linear relationship, and stable and reliable results. And avoid adding acid to the mobile phase, not only the configuration is simple, but also the life of the chromatographic column can be protected and extended, the operation is simple, the repeatability and durability are good.

Description

technical field [0001] The invention relates to a high-performance liquid chromatography analysis method, in particular to an analysis and detection method of glycocholic acid polyethylene glycol derivatives. Background technique [0002] The structural formula of glycocholic acid polyethylene glycol derivatives: [0003] [0004] Wherein, n is an integer of 1-12. [0005] So far, there is no analysis and detection method for glycocholic acid polyethylene glycol derivatives recorded in domestic and foreign pharmacopoeias and literature. [0006] In traditional technology, PEG derivatives are generally analyzed and detected by LCMS method, which has a jumpy baseline and large detection errors. And in order to improve the peak shape, it is usually necessary to add a certain proportion of acid to the mobile phase, resulting in damage to the chromatographic column. [0007] Therefore, there is an urgent need to develop a new method for the analysis and detection of glycoch...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/067
Inventor 阳杨陈芳军邓泽平罗容成佳
Owner 长沙创新药物工业技术研究院有限公司