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Detection method of moxifloxacin (R, R) isomer and application thereof

A detection method and mobile phase technology, applied in the field of detection of -isomers, can solve problems affecting the calculation of effective substance content in preparations, achieve high sensitivity and specificity, and simple operation

Inactive Publication Date: 2013-07-03
天津康鸿医药科技发展有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Moxifloxacin preparations use moxifloxacin shown in formula I as the active ingredient, but often contain a small amount of (R, R)-isomers in the preparations, and moxifloxacin (R, R)-isomers are not effective Components, its existence, will affect the calculation of the content of active substances in the preparation, and it is necessary to detect the moxifloxacin (R, R)-isomer in the moxifloxacin preparation

Method used

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  • Detection method of moxifloxacin (R, R) isomer and application thereof
  • Detection method of moxifloxacin (R, R) isomer and application thereof
  • Detection method of moxifloxacin (R, R) isomer and application thereof

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Embodiment 1

[0032] 1) Instruments and testing conditions

[0033] The Agilent 1260 high-performance liquid chromatograph produced by Agilent Corporation of the United States, the ZORBAX Eclipse Plus C18 chromatographic column (column specification: 4.6 × 250mm, 5 μm) produced by Agilent Technology Co., Ltd.; detection wavelength: 293nm; mobile phase: add L- Solvent for leucine and copper sulfate, the solvent is composed of water and acetonitrile, the ratio is to be selected, the concentration of L-leucine and copper sulfate is 0.05mol / L; flow rate: 1ml / min; column temperature: 35 ℃; injection volume: 20 μl.

[0034] 2) Experimental steps

[0035] Take an appropriate amount of the mixture composed of moxifloxacin and moxifloxacin (R, R)-isomers, add mobile phase to dissolve, and prepare a test solution with a concentration of 0.005mg / ml, and take moxifloxacin and each optical isomer The standard product of the body was configured as a standard solution as a control.

[0036] Weigh the t...

Embodiment 2

[0042] Take water as solvent, take moxifloxacin sample, prepare the solution that concentration is 1mg / ml as need testing solution, then carry out following experiment respectively, to test the specificity of the inventive method:

[0043] 1) Take 10ml of the test solution in a stoppered test tube, add 1ml of hydrochloric acid solution with a concentration of 0.1mol / L, heat it in a water bath at 90°C for 1 hour, let it cool naturally, and use a concentration of 0.1mol / L sodium hydroxide The solution is adjusted to neutral;

[0044] 2) Take 10ml of the test solution in a stoppered test tube, add 1ml of sodium hydroxide solution with a concentration of 0.1mol / L, heat it in a water bath at 90°C for 1 hour, let it cool naturally, and use 0.1mol / L sodium hydroxide solution The hydrochloric acid solution was adjusted to neutrality;

[0045] 3) Take 10ml of the test solution and place it in a stoppered test tube, heat it in a water bath at 90°C for 1 hour, leave it to cool naturally...

Embodiment 3

[0051]1) Instruments and testing conditions: Agilent 1260 high performance liquid chromatography produced by Agilent Corporation of the United States, a chromatographic column ZORBAX Eclipse Plus C18 produced by Agilent Technologies Co., Ltd. (column specification: 4.6×250mm, 5μm); detection wavelength: 293nm Mobile phase: add the solvent of chiral reagent L-leucine and copper sulfate, solvent is made up of water and acetonitrile, and volume ratio is 80: 20, and the concentration of L-leucine and copper sulfate is 0.05mol / L; : 1ml / min; Column temperature: 35°C.

[0052] 2) Preparation of the solution:

[0053] Accurately weigh 10 mg of moxifloxacin sample and add it to a 10 ml measuring bottle, dissolve it ultrasonically with pure water and dilute to the mark as the sample solution.

[0054] In addition, accurately weigh 10 mg of moxifloxacin standard substance and add it to a 10 ml volumetric flask, ultrasonically dissolve it with pure water and dilute to the mark, accuratel...

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Abstract

The present invention provides a detection method of a moxifloxacin (R, R) isomer. According to the detection method, high performance liquid chromatograph is used for detecting, wherein the conditions are that: the chromatographic column is an octadecyl silane bonded silica gel chromatographic column, and the mobile phase is a solvent containing L-leucine and metal ions, wherein the metal ions are Cu<2+>, Zn<2+> or a mixture thereof, the solvent comprises water and an organic solvent, and the volume ratio of water and the organic solvent is 77-82:23-18. The detection method provided by the present invention has high sensitivity and specificity, is simple to operate, can fast and accurately detect the moxifloxacin (R, R) isomer, can be used for quality control of moxifloxacin, lays a foundation for research and development and quality testing of the compounds, and has a practical significance.

Description

technical field [0001] The invention relates to a method for detecting (R, R)-isomers of moxifloxacin and its application, belonging to the technical field of pharmaceutical analysis, and relates to the (R, R)-isomers of moxifloxacin and related preparations Detection method. Background technique [0002] Moxifloxacin, generic name Moxifloxacin, chemical name 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrole And[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, its structure is shown in formula I. [0003] Moxifloxacin preparation is a product launched by Bayer AG of Germany. Its active ingredient is moxifloxacin or its pharmaceutically acceptable salt or its hydrate. It belongs to the fourth-generation quinolones and has broad-spectrum antibacterial activity. Moxifloxacin has two chiral centers, and its (R, R)-isomer is shown in formula II. [0004] [0005] Moxifloxacin preparations use moxifloxacin shown in formula I as the active in...

Claims

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Application Information

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IPC IPC(8): G01N30/36
Inventor 雷勇胜邹美香宋丽明孙歆慧蒋庆峰郭建锋吴疆
Owner 天津康鸿医药科技发展有限公司
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