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High-performance liquid detection method for impurity of abacavir

A high-efficiency liquid phase and detection method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of not being disclosed, affecting the purity of abacavir products, and not having good impurity detection and control, so as to improve detection and separation The effect of degree and limit of detection

Active Publication Date: 2019-01-18
SHANGHAI SHYNDEC PHARMA HAIMEN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the long-term research and development process, the inventors of the present application found that in the process of preparing abacavir (VI), due to the relationship of chemical reaction balance, there is always a small amount of raw material residues, which are brought into the subsequent reaction steps and will interact with The raw materials or products in the follow-up reaction react, so many impurities are produced in the process of synthesizing abacavir, which will affect the purity of abacavir products. At present, some impurities have been disclosed, and there are related detection and control methods , and some impurities have not been disclosed, and there is no good method to detect and control these impurities, so there is an urgent need for a scientific and effective analysis method to detect and control impurities

Method used

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  • High-performance liquid detection method for impurity of abacavir
  • High-performance liquid detection method for impurity of abacavir
  • High-performance liquid detection method for impurity of abacavir

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0053] (1) Instrument and chromatographic conditions

[0054] High performance liquid chromatography: e2965 high performance liquid chromatography system and workstation.

[0055] Column: Thermo Syncronis C 18 (4.6mm×250mm, 5μm) octadecylsilane bonded silica gel column.

[0056] Mobile phase: prepare a 0.05% volume concentration of trifluoroacetic acid-water solution, prepare a mixed solution of water / methanol (15 / 85), mix the trifluoroacetic acid-water solution and water-methanol mixture to obtain a mobile phase, and in the mobile phase Trifluoroacetic acid solution-(water / methanol=15 / 85) according to the ratio of 0~20min, 20~35min, 35~35.1min, 35.1~50min time points, the acid solution volume ratio is 95~70%, 70~10% , 10-95%, 95-95% for gradient elution.

[0057] Detection conditions: Set the flow rate to 1.0ml / min, the detection wavelength to 254nm, and the column temperature to 30°C.

[0058] (2) Experimental steps

[0059] Prepare sample analysis solution:

[0060] T...

experiment example 2

[0065] (1) Instrument and chromatographic conditions

[0066] High performance liquid chromatography: e2965 high performance liquid chromatography system and workstation.

[0067] Chromatographic column: Waters symmetry C18 (3.9*150mm, 5um) octadecylsilane bonded silica gel chromatographic column.

[0068] Mobile phase: Prepare trifluoroacetic acid-water solution with 0.02% volume concentration, prepare a mixed solution of water / methanol (15 / 85), mix trifluoroacetic acid-water solution with water-methanol mixture to prepare mobile phase, in mobile phase Trifluoroacetic acid solution-(water / methanol=15 / 85) according to the ratio of 0~20min, 20~35min, 35~35.1min, 35.1~50min time points, the acid solution volume ratio is 95~70%, 70~10% , 10-95%, 95-95% for gradient elution.

[0069] Detection conditions: Set the flow rate to 1.0ml / min, the detection wavelength to 254nm, and the column temperature to 30°C.

[0070] (2) Experimental steps

[0071] Prepare sample analysis soluti...

experiment example 3

[0077] (1) Instrument and chromatographic conditions

[0078] High performance liquid chromatography: e2965 high performance liquid chromatography system and workstation.

[0079] Chromatographic column: Waters symmetry C18 (3.9*150mm, 5um) octadecylsilane bonded silica gel chromatographic column.

[0080] Mobile phase: prepare a 0.05% volume concentration of trifluoroacetic acid-water solution, prepare a mixed solution of water / methanol (15 / 85), mix the trifluoroacetic acid-water solution and water-methanol mixture to obtain a mobile phase, and in the mobile phase Trifluoroacetic acid solution-(water / methanol=15 / 85) according to the ratio of 0~20min, 20~35min, 35~35.1min, 35.1~50min time points, the acid solution volume ratio is 95~70%, 70~10% , 10-95%, 95-95% for gradient elution.

[0081] Detection conditions: Set the flow rate to 1.0ml / min, the detection wavelength to 254nm, and the column temperature to 30°C.

[0082] (2) Experimental steps

[0083] Prepare sample ana...

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Abstract

The present application discloses a high-performance liquid detection method for an impurity of abacavir. The structural formula of the impurity is formula, wherein R is an alkyl group, an alkenyl group, an alkynyl group, an aryl group, a hydroxyl group, a halogen group, a hydroxyalkyl group, a carboxyl group or an ester group. The method comprises the following steps: providing a sample analysissolution; injecting the sample analysis solution into a high-performance liquid chromatograph for chromatographic analysis and recording a chromatogram map, wherein the chromatographic column used isa reversed phase chromatographic column, and the mobile phase used is a mixed liquor of an acid solution and a solvent phase. In the above manner, the high-performance liquid detection method for an impurity of abacavir in the present application can improve the degree of separation and accuracy of detection.

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 impurities of abacavir. Background technique [0002] Abacavir (ABC) is a new anti-AIDS drug. It is a new carbocyclic 2'-deoxyguanosine nucleoside drug. It has high oral bioavailability and easily penetrates into the central nervous system. Like other nucleoside reverse transcriptase inhibitors, it is an inactive prodrug that is metabolized into an active triphosphate through four steps in the body, and inhibits human immunodeficiency virus (HIV) through the following two pathways: ) The role of reverse transcriptase: ① Competitively inhibit 2'-deoxyguanosine triphosphate (dGTP) (one of the DNA synthesis fragments) from incorporation into the nucleic acid chain. ② Effectively terminate DNA chain synthesis by preventing the addition of new bases. The chemical structural formula of abacavir is as follows: [0003] ...

Claims

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Application Information

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IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 周洁丁屏陈婷婷
Owner SHANGHAI SHYNDEC PHARMA HAIMEN CO LTD
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