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High-performance liquid detection method for genotoxic impurities of zidovudine

A technology of zidovudine and genotoxicity, which is applied in the field of drug analysis, can solve the problems of inability to quantitatively control genotoxic impurities, low limits of genotoxic impurities, and the influence of quantitative tailing, etc., to improve the detection resolution and detection limit, The effect of increasing the service life and reducing the concentration

Inactive Publication Date: 2019-01-15
SHANGHAI SHYNDEC PHARMA HAIMEN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the long-term research and development process, the inventors of the present application found that due to the extremely low limit of genotoxic impurities, a large injection concentration is required in the detection process, and when the injection concentration becomes larger, the product peak in the sample analysis solution is inevitable. There will be tailing phenomenon due to sample overload, and the quantification of impurities with similar polarity to the product will inevitably be affected by the tailing of the main peak, and the quantitative control of genotoxic impurities cannot be well performed. Therefore, it is urgent to develop a detection kit Method for Genotoxic Impurities of Dovudine

Method used

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  • High-performance liquid detection method for genotoxic impurities of zidovudine

Examples

Experimental program
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Effect test

experiment example 1

[0050] (1) Instrument and chromatographic conditions

[0051] High performance liquid chromatography: e2965 high performance liquid chromatography system and workstation.

[0052] Chromatographic column: Thermo Syncronis C18 (4.6mm×250mm, 5μm) octadecylsilane bonded silica gel chromatographic column.

[0053] Mobile phase: prepare 0.020mol / L ammonium acetate solution, adjust the pH value to 4.5 with glacial acetic acid, and mix the ammonium acetate solution with methanol as the water phase to obtain the mobile phase; wherein, the ratio of water phase-methanol in the mobile phase is as follows: At time points of 0, 8, 20, 25, and 35 minutes, the volume ratio of the aqueous phase was 90%, 35%, 10%, 90%, and 90% for mixing.

[0054] Detection conditions: set the flow rate of the mobile phase to 1.0ml / min, the detection wavelength to 265nm, and the column temperature to 35°C.

[0055] (2) Experimental steps

[0056] Prepare sample analysis solution:

[0057] Take predetermined...

experiment example 2

[0062] (1) Instrument and chromatographic conditions

[0063] High performance liquid chromatography: e2965 high performance liquid chromatography system and workstation.

[0064] Chromatographic column: Thermo Syncronis C18 (4.6mm×250mm, 5μm) octadecylsilane bonded silica gel chromatographic column.

[0065] Mobile phase: prepare 0.020mol / L ammonium acetate solution, adjust the pH value to 5.0 with glacial acetic acid, and mix the ammonium acetate solution with methanol as the water phase to obtain the mobile phase; wherein, the ratio of water phase-methanol in the mobile phase is as follows: At time points of 0, 8, 20, 25, and 35 minutes, the volume ratio of the aqueous phase was 90%, 30%, 5%, 90%, and 90% for mixing.

[0066] Detection conditions: set the flow rate of the mobile phase to 1.0ml / min, the detection wavelength to 265nm, and the column temperature to 40°C.

[0067] (2) Experimental steps

[0068] Prepare sample analysis solution:

[0069] Take predetermined ...

experiment example 3

[0074] (1) Instrument and chromatographic conditions

[0075] High performance liquid chromatography: e2965 high performance liquid chromatography system and workstation.

[0076] Chromatographic column: Agilent ZORBAX SB-CN (4.6mm×250mm, 5μm) cyano-bonded silica gel chromatographic column.

[0077] Mobile phase: prepare 0.020mol / L ammonium acetate solution, adjust the pH value to 5.5 with glacial acetic acid, and mix the ammonium acetate solution with methanol as the water phase to obtain the mobile phase; wherein, the ratio of water phase-methanol in the mobile phase is as follows: At time points of 0, 8, 20, 25, and 35 minutes, the volume ratio of the aqueous phase was 90%, 30%, 5%, 90%, and 90% for mixing.

[0078] Detection conditions: set the flow rate of the mobile phase to 1.0ml / min, the detection wavelength to 265nm, and the column temperature to 40°C.

[0079] (2) Experimental steps

[0080] Prepare sample analysis solution:

[0081] Take predetermined amounts of...

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Abstract

The present application discloses a high-performance liquid detection method for the genotoxic impurities of the zidovudine. The method comprises the following steps of: providing a sample analysis solution; injecting the sample analysis solution into a high performance liquid chromatograph for chromatographic analysis, and recording a chromatogram; a chromatography column is a reverse phase chromatography column, and a mobile phase is a mixture of an acid ammonium salt solution and the organic phase. According to the high-performance liquid detection method for the genotoxic impurities of thezidovudine, the detection separation and the detection limit of the genotoxic impurities can be improved by the means.

Description

technical field [0001] The application relates to the technical field of drug analysis, in particular to a high-performance liquid phase detection method for genotoxic impurities of zidovudine. Background technique [0002] Zidovudine, chemical name l-(3-azido-2,3-dideoxy-β-D-ribofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione, Its structural formula is: [0003] Zidovudine, 3'-azido-3'-deoxythymidine, is a synthetic analogue of natural thymidine. It is the first new drug on the market for the treatment of acquired immunodeficiency syndrome (AIDS). It binds to the viral DNA polymerase to stop the growth of the DNA chain, thereby inhibiting the replication of the virus. The British Glaxo Company was the first to successfully develop and market it, and it has been widely used clinically to treat HIV infection, AIDS and severe AIDS-related syndromes. [0004] The impurities imp2 / imp3 / imp4 generated during the synthesis of zidovudine (see Table 1 for specific structures) all...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/74
CPCG01N30/02G01N30/06G01N30/74G01N2030/027
Inventor 周洁李春刚丁屏高衎葛红娟施健峰
Owner SHANGHAI SHYNDEC PHARMA HAIMEN CO LTD
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