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A method for the separation and determination of moxifloxacin hydrochloride and its enantiomers

A technology for moxifloxacin hydrochloride and enantiomers, which is applied in the field of separation and determination of moxifloxacin hydrochloride and its enantiomers, can solve the threat to the safety of clinical medication and the unspecified enantiomer check items and limits and other issues, to achieve the effect of low cost, strong specificity and accurate detection

Inactive Publication Date: 2015-09-30
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At the same time, moxifloxacin hydrochloride and its preparations that have been marketed at home and abroad have no enantiomer inspection items and limits in the quality standards, which poses a potential threat to the safety of clinical medication

Method used

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  • A method for the separation and determination of moxifloxacin hydrochloride and its enantiomers
  • A method for the separation and determination of moxifloxacin hydrochloride and its enantiomers
  • A method for the separation and determination of moxifloxacin hydrochloride and its enantiomers

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Experimental program
Comparison scheme
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Embodiment 1

[0095] The determination of embodiment 1 moxifloxacin hydrochloride and its enantiomer

[0096] Chromatographic conditions Shimadzu LC-2010AHT high performance liquid chromatograph, LCsolution workstation, use octylsilane bonded silica gel as filler, use copper sulfate D-phenylalanine solution (the moles of copper sulfate and D-phenylalanine The ratio is 1:2, add water to dissolve and prepare copper sulfate concentration of 4mmol / L, adjust pH to 4.0)-methanol (75:25) as mobile phase, column temperature: 35°C; flow rate: 1.0ml / min; detection The wavelength is: 293nm.

[0097] Sample preparation Take about 30mg of moxifloxacin hydrochloride, put it in a 50ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution; take another about 15mg of moxifloxacin hydrochloride racemate, put it in a 100ml measuring bottle Add mobile phase to dissolve and dilute to the mark, shake well, take 1ml, put it in a 10ml measuring bottle, ...

Embodiment 2

[0103] The determination of embodiment 2 moxifloxacin hydrochloride and its enantiomer

[0104] Chromatographic conditions Shimadzu LC-2010AHT high performance liquid chromatography, LCsolution workstation, using octadecylsilane bonded silica gel as filler, copper sulfate L-phenylalanine solution (copper sulfate and L-phenylalanine The molar ratio is 1:4.5, add water to dissolve and prepare copper sulfate concentration of 3mmol / L, adjust pH to 4.5)-methanol (79:21) as mobile phase, column temperature: 30°C; flow rate: 0.8ml / min; The detection wavelength is: 293nm.

[0105] Sample preparation Take about 35mg of moxifloxacin hydrochloride, put it in a 50ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution; take another about 20mg of moxifloxacin hydrochloride racemate, put it in a 100ml measuring bottle Add mobile phase to dissolve and dilute to the mark, shake well, take 1ml, put it in a 100ml measuring bottle, a...

Embodiment 3

[0111] The determination of embodiment 3 moxifloxacin hydrochloride and its enantiomer

[0112]Chromatographic conditions Shimadzu LC-2010AHT high performance liquid chromatograph, LCsolution workstation, using octadecylsilane bonded silica gel as filler, copper sulfate L-isoleucine solution (copper sulfate and L-isoleucine The molar ratio is 1:5.5, add water to dissolve and prepare copper sulfate concentration of 2mmol / L, adjust pH to 3.5)-methanol (77:23) as mobile phase, column temperature: 40°C; flow rate: 1.0ml / min; The detection wavelength is: 293nm.

[0113] Sample preparation Take about 45mg of moxifloxacin hydrochloride, put it in a 100ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution; take another about 13mg of moxifloxacin hydrochloride racemate, put it in a 100ml measuring bottle Add mobile phase to dissolve and dilute to the mark, shake well, take 1ml, put it in a 10ml measuring bottle, add mobil...

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Abstract

The invention discloses a method for separating and measuring moxifloxacin hydrochloride and an enantiomer thereof. According to the method, high performance liquid chromatography is adopted, a reversed phase column is used, a chiral reagent serves as a mobile phase, the enantiomer in the moxifloxacin hydrochloride is positioned according to a moxifloxacin hydrochloride racemate, the enantiomer of the moxifloxacin hydrochloride existing in various dosage forms including sustained release type, controlled release type or common tablets, capsules, granules, oral liquid, injection, eye drops, nasal drops, auristilla, suppository or injection can be checked, the quality standard of the conventional moxifloxacin hydrochloride is improved, and a basis is provided for setting an enantiomer measurement standard of the moxifloxacin hydrochloride in the future.

Description

technical field [0001] The invention relates to a detection method of medicines, in particular to a method for separation and determination of moxifloxacin hydrochloride and its enantiomers. Background technique [0002] Moxifloxacin hydrochloride is a broad-spectrum and 8-methoxyfluoroquinolone antibacterial drug with antibacterial activity listed in the United States. It is used as an antibiotic drug for adults with upper and lower respiratory tract infections. Molecular formula is C 21 h 25 ClFN 3 o 4 , the chemical name is 1-cyclopropyl-7-(S,S-2,8-diazo-bicyclo[4.3.0]nonan-8-yl)-6-fluoro-8-methoxy-1, 4-dihydro-4-oxo-3-quinoline carboxylic acid hydrochloride, its chemical structure is as follows: [0003] [0004] The enantiomer of moxifloxacin hydrochloride is 1-cyclopropyl-7-(R,R-2,8-diazo-bicyclo[4.3.0]nonan-8-yl)-6-fluoro-8 - Methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylate hydrochloride. Moxifloxacin hydrochloride enantiomers are introduced by chiral side c...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/36
Inventor 易崇勤朱丹崔畅郭欲晓郑少辉苏强
Owner NEW FOUNDER HLDG DEV LLC
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