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Method for detecting potential genotoxic impurities in linezolid

A technology of genotoxicity and linezolid, which is applied in the field of analytical chemistry, can solve problems such as undiscovered detection methods and sensitivity that cannot meet the detection requirements, and achieve the effects of good linear relationship, high sensitivity, good precision and durability

Active Publication Date: 2022-07-05
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The sensitivity of conventional gas chromatography or liquid chromatography detection methods cannot meet the detection requirements of the above-mentioned haloalkane genotoxic impurities in linezolid raw materials
At present, there is no detection method report that can meet this requirement

Method used

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  • Method for detecting potential genotoxic impurities in linezolid
  • Method for detecting potential genotoxic impurities in linezolid
  • Method for detecting potential genotoxic impurities in linezolid

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Experimental program
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Embodiment 1

[0037] The detection method of potential genotoxic impurities in linezolid specifically includes the following steps:

[0038] 1.1 Solution preparation

[0039] Precisely weigh 1 g of the test sample and place it in a headspace vial, add 5 mL of dimethyl sulfoxide solution and seal it immediately as the test sample solution;

[0040] Precise appropriate amounts of epichlorohydrin, 1,3-dichloropropene, 1,1,2-trichloropropane and 1,2,3-trichloropropane were respectively dissolved in dimethyl sulfoxide, diluted and mixed to make Each 1ml contains a mixed solution of about 50.00 μg of epichlorohydrin, 20.00 μg of 1,3-dichloropropene, 20.00 μg of 1,1,2-trichloropropane and 30.00 μg of 1,2,3-trichloropropane, as a control product stock solution;

[0041] Precise appropriate amounts of epichlorohydrin, 1,3-dichloropropene, 1,1,2-trichloropropane and 1,2,3-trichloropropane were respectively dissolved in dimethyl sulfoxide, diluted and mixed to make Each 1ml of a mixed solution cont...

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Abstract

The invention relates to the field of analytical chemistry, in particular to a method for detecting potential genotoxic impurities in linezolid. For potential genotoxic impurities such as epichlorohydrin, 1, 3-dichloropropene, 1, 1, 2-trichloropropane and 1, 2, 3-trichloropropane in linezolid, the headspace sampling-gas chromatography-mass spectrum combined detection method provided by the invention has the advantages of high sensitivity, accuracy, reliability and good linear relationship through limitation of parameter conditions, and can be used for detecting the potential genotoxic impurities such as the epichlorohydrin, the 1, 3-dichloropropene, the 1, 1, 2-trichloropropane and the 1, 2, 3-trichloropropane in the linezolid. Meanwhile, the method has good precision and durability, is suitable for detection of potential genotoxic impurities in linezolid, and can be used as a basis for quality monitoring of the linezolid.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for detecting potential genotoxic impurities in linezolid. Background technique [0002] Linezolid is a new type of oxazolidinone chemically synthesized antibacterial drug, which mainly acts on the initial stage of bacterial protein translation and synthesis. Initiating complex formation, thereby preventing bacterial protein synthesis and exerting a bacteriostatic effect. Linezolid has no cross-resistance with other antibacterial drugs, and has strong antibacterial activity against vancomycin-resistant enterococci (VRE), methicillin-resistant Staphylococcus (MRSA), acquired pneumonia and skin and soft tissue infections. for the treatment of Gram-positive (G + ) cocci, including suspected or confirmed hospital-acquired pneumonia (HAP) caused by MRSA, community-acquired pneumonia (CAP), complicated skin or skin and soft tissue infections (SSTI), and vancomycin-resista...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/20G01N30/72G01N30/86
CPCG01N30/02G01N30/20G01N30/72G01N30/8679
Inventor 徐黎明王亚静董海峰荣孜杭周雅洁祝春英韩倩茹骆会茹
Owner SHIJIAZHUANG NO 4 PHARMA
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