Quality control method for ornidazole

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...

AI Technical Summary

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 during the sterilization process, in order to strictly control For the quality of ornidazole, a quality detection method for ornidazole must be developed, but the existing detection methods have poor separation effects, low detection sensitivity, and poor stability, especially the simultaneous detection of active ingredients ornidazole and impurities such as 2 - Content of methyl-5-nitroimidazole

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