Quality control method for ornidazole

A quality control method and technology for ornidazole, applied in the field of quality control of ornidazole injection, can solve problems such as poor stability, low detection sensitivity, and inability to detect at the same time, and achieve the effects of good separation degree and good separation effect.

Inactive Publication Date: 2012-07-11
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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Problems solved by technology

The structure of ornidazole is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, and the chemical structure of ornidazole will change under the condition of heating or strong light irradiation to generate other Impurities, wherein 2-methyl-5-nitroimidazole is one of the impurity components in ornidazole injection, and ornidazole injection must be sterilized at high temperature duri...

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  • Quality control method for ornidazole
  • Quality control method for ornidazole
  • Quality control method for ornidazole

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Embodiment Construction

[0023] The present invention is further illustrated below in conjunction with specific embodiments, should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention, after having read the present invention, those skilled in the art will understand the various equivalent forms of the present invention All modifications fall within the scope defined by the appended claims of this application.

[0024] Implementation column: the quality control method of ornidazole comprises the following steps:

[0025] (1) Preparation of standard substance: take 50 mg of ornidazole standard substance, dilute it with methanol-water-glacial acetic acid with a volume ratio of 30:70:0.2 to be a solution of 500 μg / ml ornidazole standard substance, and take another 25 mg of 2-methyl-5-nitroimidazole standard substance, diluted with methanol-water-glacial acetic acid with a volume ratio of 30:70:0.2 to a conc...

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Abstract

The invention discloses a quality control method for ornidazole, which adopts the high performance liquid chromatography for on-line detecting ornidazole and impurity constituent such as 2-methyl-5-nitroimidazole at the same time. According to the invention, the optimal mobile phase composition, elution procedure, flow velocity, detection wave length, chromatographic columns and other analysis conditions can be preferably selected through plenty of experiments, and as verified and proved through many experiments, the quality control method for ornidazole provided by the invention has excellent stability and repeatability, high analysis efficiency and excellent separation degree, and can be used for qualitative and quantitative detections for compounds sensitively and accurately, thereby being used for objectively, comprehensively and accurately evaluating the quality of ornidazole injection, and having vital significances to the quality control of ornidazole injection and assurance of the clinical curative effect.

Description

technical field [0001] The invention relates to a quality control method of pharmaceutical preparations, in particular to a quality control method of ornidazole injection. Background technique [0002] Ornidazole is the third generation of nitroimidazole derivatives. Ornidazole has a wide range of clinical applications and can be used to treat diseases caused by B. A variety of infectious diseases caused by sensitive anaerobic bacteria such as Bacillus, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori, Bacteroides melaninus, Fusobacterium, CO2 Phagocytosis, and Bacteroides gingivalis. The structure of ornidazole is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole, and the chemical structure of ornidazole will change under the condition of heating or strong light irradiation to generate other Impurities, wherein 2-methyl-5-nitroimidazole is one of the impurity components in ornidazole injection, and ornidazole injection must be sterilized at high te...

Claims

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Application Information

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IPC IPC(8): G01N30/89
Inventor 顾林肖鑫王丽楠
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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