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Method for simultaneously detecting multiple residual solvents in sitafloxacin

A technology for residual solvents and sitafloxacin, which is applied in the field of analytical chemistry, can solve the problem that multiple residual solvents of sitafloxacin cannot be detected at the same time, and achieve the effects of saving manpower and material resources, reducing interference, and improving detection efficiency

Pending Publication Date: 2020-10-09
JUMPCAN PHARMA GRP
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] In order to make up for the gaps in the prior art and solve the current problem of being unable to simultaneously detect multiple residual solvents in sitafloxacin, the present invention provides a method for simultaneously detecting up to 11 residual solvents in sitafloxacin by gas chromatography

Method used

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  • Method for simultaneously detecting multiple residual solvents in sitafloxacin
  • Method for simultaneously detecting multiple residual solvents in sitafloxacin
  • Method for simultaneously detecting multiple residual solvents in sitafloxacin

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Embodiment

[0101] Example: Simultaneous detection of 11 residual solvents in sitafloxacin.

[0102] 1. Instruments and reagents:

[0103] Gas spectrometer: GC-2010Pro gas chromatograph, produced by Shimadzu Corporation of Japan;

[0104] Headspace sampler: HS-20 type headspace sampler, produced by Shimadzu Corporation of Japan;

[0105] Drug: sitafloxacin (batch number: 1811013), produced by Jichuan Pharmaceutical Group Co., Ltd.;

[0106] Solvent: N,N-dimethylacetamide (DMAC), GC grade, produced by CNW Technology Co., Ltd., Germany.

[0107] Reference substances: methanol, acetonitrile, tert-butanol, dichloromethane, methyl tert-butyl ether, n-hexane, ethyl acetate, tetrahydrofuran and dioxane, GC grade, all produced by Shanghai Aladdin Biochemical Technology Co., Ltd. ; Ethanol, GC grade, produced by West Asia Chemical Technology (Shandong) Co., Ltd.; Toluene, GC grade, produced by TEDIA Co., Ltd. of the United States.

[0108] 2. Chromatographic conditions:

[0109] In this embod...

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Abstract

The invention belongs to the technical field of analytical chemistry, and relates to a method for simultaneously detecting multiple residual solvents in sitafloxacin. Specifically, the method comprises the following steps: 1) determining gas chromatography conditions; 2) preparing a reference solution and a test solution; 3) performing methodology verification; and 4) determining the residual solvent in the sitafloxacin sample. The method can effectively and accurately detect 11 residual solvents such as methanol, ethanol, acetonitrile, tert-butyl alcohol, dichloromethane, methyl tert-butyl ether, n-hexane, ethyl acetate, tetrahydrofuran, dioxane and toluene at the same time, and is wide in application range and high in detection efficiency. A weak-polarity capillary chromatographic columnis selected, so that a relatively good separation effect can be achieved. Meanwhile, a headspace sample injection method is adopted, so that the interference of direct sample injection of a solutionsample to detection and the pollution to a chromatographic column are reduced.

Description

technical field [0001] The invention belongs to the technical field of analytical chemistry and relates to a method for simultaneously detecting multiple residual solvents in sitafloxacin. Background technique [0002] Sitafloxacin (Sitafloxacin / STFX / DU-6859a) is a quinolone broad-spectrum antibacterial drug developed by Daiichi Sankyo, Japan, with a CAS number of 127254-12-0 and a chemical name of 7- [(7S)-7-Amino-5-azaspiro[2.4]hept-5-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-1 , 4-dihydro-4-oxoquinoline-3-carboxylic acid (the structural formula is shown below), its hydrate form is often used clinically for the treatment of severe bacterial infections or bacterial infections caused by drug-resistant bacteria. [0003] [0004] Through the analysis of the existing synthesis process of sitafloxacin, it is found that there may be 11 kinds of organic solvents with potential safety hazards in the product, which are hydrocarbons (n-hexane, toluene), halogenated h...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8675G01N2030/065
Inventor 曹龙祥杨学芳苏万福吴佳美蔡虎
Owner JUMPCAN PHARMA GRP
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