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A pharmaceutical analysis method for efficiently determining gangliosides GM1 and impurities thereof

A ganglioside and high performance liquid chromatography technology is applied in the field of drug analysis for the efficient determination of ganglioside GM1 single component and related substances, and can solve the problems of ineffective separation, weakened detection sensitivity of impurities, underestimation of impurities and the like, Achieve the effect of being beneficial to product quality control, excellent separation selectivity, and good reference peak shape

Active Publication Date: 2019-05-07
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The selectivity of the above method is limited, the separation ability is weak, and there is a risk that related substances with similar structures cannot be effectively separated; using 205nm low ultraviolet wavelength as the detection wavelength and tetrahydrofuran as the mobile phase increases the basic absorption value of the baseline and increases the baseline noise. The detection sensitivity of impurities will be weakened accordingly, and there is a risk of underestimating impurities or even incomplete analysis of impurity profiles; and the stability and reproducibility of the method are poor

Method used

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  • A pharmaceutical analysis method for efficiently determining gangliosides GM1 and impurities thereof
  • A pharmaceutical analysis method for efficiently determining gangliosides GM1 and impurities thereof
  • A pharmaceutical analysis method for efficiently determining gangliosides GM1 and impurities thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The mensuration of embodiment 1 ganglioside GM1

[0054] Instruments and Conditions

[0055] High performance liquid chromatography: Waters e2695-2489

[0056] Chromatographic column: C18 (Waters, 4.6×150mm, 3.5μm)

[0057] Mobile phase A: 0.01mol / L potassium dihydrogen phosphate solution-acetonitrile (30:70), adjust pH=7.1 with triethylamine.

[0058] Mobile Phase B: Acetonitrile

[0059] The gradient elution procedure was used as follows:

[0060]

[0061] Flow rate: 1.0ml / min, detection wavelength: 205nm, injection volume: 10μl, column temperature: 40°C.

[0062] Experimental steps:

[0063] Take an appropriate amount of ganglioside GM1 and its related substances, dissolve the sample with an aqueous solution, and prepare a sample solution containing about 1.0 mg / ml of ganglioside GM1. Carry out HPLC analysis by above-mentioned test condition, record chromatogram, its HPLC collection of illustrative plates is as follows figure 2 shown. The content was calc...

Embodiment 2

[0065] Determination of embodiment 2 ganglioside GM1

[0066] Instruments and Conditions

[0067] High performance liquid chromatography: Agilent 1260-VWD

[0068] Chromatographic column: C18 (Waters, 4.6×150mm, 3.5μm)

[0069] Mobile phase A: 0.01mol / L potassium dihydrogen phosphate solution-acetonitrile (32:68), adjust pH=7.1 with triethylamine.

[0070] Mobile Phase B: Acetonitrile

[0071] The gradient elution procedure was used as follows:

[0072]

[0073] Flow rate: 1.2ml / min, detection wavelength: 205nm, injection volume: 10μl, column temperature: 40°C.

[0074] Experimental steps:

[0075] Take an appropriate amount of ganglioside GM1 and its related substances, dissolve the sample with an aqueous solution, and prepare a sample solution containing about 5 mg / ml of ganglioside GM1. Carry out high performance liquid chromatography analysis according to above-mentioned gradient condition, record chromatogram, two components of ganglioside GM1 and its related sub...

Embodiment 3

[0076] Determination of embodiment 3 ganglioside GM1

[0077] Instruments and Conditions

[0078] High performance liquid chromatography: Waters e2695-2489

[0079] Chromatographic column: C18 (Symmetry RP18, 4.6×150mm, 3.5μm)

[0080] Mobile phase A: 0.012mol / L potassium dihydrogen phosphate solution-acetonitrile (35:65), adjust pH=7.5 with triethylamine.

[0081] Mobile Phase B: Acetonitrile

[0082] The gradient elution procedure was used as follows:

[0083]

[0084] Flow rate: 1.2ml / min, detection wavelength: 205nm, injection volume: 10μl, column temperature: 40°C.

[0085] Experimental steps:

[0086] Take an appropriate amount of ganglioside GM1 and its related substances, dissolve the sample with an aqueous solution, and prepare a sample solution containing about 1.2 mg / ml of ganglioside GM1. Carry out high-performance liquid chromatography analysis according to above-mentioned gradient condition, record chromatogram, the result sees attached Figure 4 . The...

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Abstract

The invention discloses a pharmaceutical analysis method for efficiently determining gangliosides GM1 and impurities thereof, and belongs to the technical field of pharmaceutical analysis. According to the method, a chromatographic column taking octadecylsilane chemically bonded silica as a filler is used as a stationary phase, and a mixed solution of a buffer salt solution and an organic phase isused as a mobile phase, so that the gangliosides GM1 related substances and content can be effectively separated and determined.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a drug analysis method for efficiently measuring ganglioside GM1 single component and related substances. The analysis method can effectively separate and determine the content of the ganglioside GM1 single component and its related impurities, has the advantages of simple and fast operation, and can be used as an important part of the quality control of the ganglioside GM1. Background technique [0002] Gangliosides (gangliosides) are the most complex glycosphingolipids, widely distributed in the cell membranes of vertebrates, and have the highest content in the central nervous system. It is composed of oligosaccharide chains with sialic acid and ceramide, and gangliosides can be classified according to the number of sugar groups of sialic acid and oligosaccharides and the connection sites of sialic acid. The gangliosides with higher content are GM1, GDla, GDlb, GD3 and G...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/06G01N30/74G01N2030/047
Inventor 李慧姜小平宋玉平魏长峰李晓磊管凯林翟建华邹丽红吕园园马明辉梁鑫淼郭志谋丰加涛
Owner QILU PHARMA
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