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Pazufloxacin mesilate and quality control method of injection preparation

A technology of pazufloxacin mesylate and quality control method, which is applied in the field of quality control of pazufloxacin mesylate and injection preparations to achieve the effect of accurate quantitative determination of impurities

Active Publication Date: 2014-03-26
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dextro isomer has no active ingredients, and its content needs to be controlled as an impurity in the actual development and production. However, there is no literature at present about the dextro isomerism in pazufloxacin mesylate and injection preparations. Body content control method

Method used

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  • Pazufloxacin mesilate and quality control method of injection preparation
  • Pazufloxacin mesilate and quality control method of injection preparation
  • Pazufloxacin mesilate and quality control method of injection preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: Dextroisomer content in pazufloxacin mesylate determined by high performance liquid chromatography

[0023] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler, dissolve in water (take 0.5g of copper sulfate and 0.5g of D-phenylalanine in 0.1mol / L potassium dihydrogen phosphate buffer solution In 2000ml, adjust the pH value to 2.0 with phosphoric acid]-methanol (50:50) as the mobile phase, and the detection wavelength is 293nm.

[0024] Preparation of the test solution: take an appropriate amount of pazufloxacin mesylate sample, add mobile phase to make a solution containing 0.3mg in every 1ml, as the test solution.

[0025] Preparation of contrast solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as contrast solution.

[0026] Preparation of reference substance solution: Take an appropriate amount of ...

Embodiment 2

[0028] Embodiment 2: the content of dextrorotatory isomer in Pazufloxacin mesylate determined by high performance liquid chromatography

[0029] Chromatographic conditions and system suitability test: use octaalkylsilane bonded silica gel as filler, dissolve 0.5g copper sulfate and 0.5g D-phenylalanine in 0.1mol / L potassium dihydrogen phosphate buffer 2000ml In the method, the pH value was adjusted to 6.0 with phosphoric acid]-methanol (80:20) was used as the mobile phase, and the detection wavelength was 293nm.

[0030] Preparation of the test solution: take an appropriate amount of pazufloxacin mesylate sample, add mobile phase to make a solution containing 0.3mg in every 1ml, as the test solution.

[0031] Preparation of contrast solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as contrast solution.

[0032] Preparation of reference substance solution: Take an appropria...

Embodiment 3

[0034] Embodiment 3: the content of dextrorotatory isomer in pazufloxacin mesylate determined by high performance liquid chromatography

[0035] Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler, dissolve 0.5g copper sulfate and 0.5g D-phenylalanine in 0.1mol / L sodium acetate buffer 2000ml with water , adjust the pH value to 4.0 with phosphoric acid] - acetonitrile (50:50) as the mobile phase, the detection wavelength is 293nm.

[0036] Preparation of the test solution: take an appropriate amount of pazufloxacin mesylate sample, add mobile phase to make a solution containing 0.3mg in every 1ml, as the test solution.

[0037] Preparation of contrast solution: Accurately measure 1ml of the test solution, put it in a 200ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as contrast solution.

[0038] Preparation of reference substance solution: Take an appropriate amount of pazufloxacin mesyla...

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Abstract

The invention discloses pazufloxacin mesilate and a quality control method of an injection preparation. According to the method, high performance liquid chromatography is employed for performing quantitative determination on pazufloxacin mesilate and an impurity pazufloxacin mesilate dextroisomer in the preparation. The technical scheme provided by the invention is capable of relatively reliably and relatively accurately evaluating and controlling the quality of pazufloxacin mesilate and the injection preparation.

Description

technical field [0001] The invention relates to a quality control method of a medicine and its preparation, in particular to a quality control method of pazufloxacin mesylate and an injection preparation. Background technique [0002] Pazufloxacin Mesylate (Pazufloxacin Mesylate) is one of the quinolones, its chemical name is (S)-(-)-10-(1-aminocyclopropyl)-9-fluoro-3-methyl yl-7-oxo-2,3-dihydro-7H-pyridine[1,2,3-de][1,4]benzoxazine-6-carboxylic acid methanesulfonate, formula C 16 h 15 FN 2 o 4 ·CH 4 o 3 S, the chemical structural formula is as follows: [0003] . [0004] Pazufloxacin mesilate is a quinolone antibiotic firstly researched and developed by Japan Toyama Chemical Co., Ltd., and it was approved for marketing in Japan for the first time in April 2002. Two large-volume injections of Pazufloxacin base, the trade name is Pazucross. This product is suitable for the following infections caused by sensitive bacteria: (1) Secondary infection of chronic respir...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 周玲玲吕吉祥范建伟崔良峰
Owner SHANDONG QIDU PHARMA
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