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Quality control method of pazufloxacin mesylate injection

A technology of pazufloxacin mesylate and quality control method, which is applied in the field of quality control of pazufloxacin mesylate injection, can solve problems such as the generation of photodegradable impurities and the separation of non-degradable impurities, and achieve accurate results and methods Sensitive and repeatable effect

Pending Publication Date: 2022-04-15
四川美大康佳乐药业有限公司
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Problems solved by technology

[0005] However, the isocratic elution chromatographic conditions of the existing quality standards for raw materials of pazufloxacin mesylate injection cannot remove the main degradation impurities (especially photodegradation impurities) before the main peak of pazufloxacin mesylate injection. ) separation
Pazufloxacin mesylate injection will be exposed to light during production and use, which may produce photodegradation impurities

Method used

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  • Quality control method of pazufloxacin mesylate injection
  • Quality control method of pazufloxacin mesylate injection
  • Quality control method of pazufloxacin mesylate injection

Examples

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Embodiment 1

[0055] Related substances were determined according to high performance liquid chromatography (Chinese Pharmacopoeia 2020 Edition Sibu General Rules 0512).

[0056] 1. Mixed solvents Take 85ml of mobile phase A and 15ml of mobile phase B, mix well, and get ready.

[0057] 2. The test solution Take an appropriate amount of this product (pazufloxacin mesylate injection) and dilute it with a mixed solvent to make a solution containing about 0.24mg of pazufloxacin per 1ml.

[0058] 3. Control solution Accurately measure an appropriate amount of the test solution, and quantitatively dilute it with a mixed solvent to prepare a solution containing about 0.48 μg of pazufloxacin mesylate per 1 ml.

[0059] 4. Sensitivity solution Accurately measure an appropriate amount of Pazufloxacin mesylate reference substance solution under the content determination item, and quantitatively dilute it with a mixed solvent to make a solution containing about 0.06μg per 1ml.

[0060] 5. Chromatograp...

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Abstract

The invention relates to the technical field of pharmaceutical analysis and provides a quality control method of a pazufloxacin mesilate injection, which is used for solving the problem that the existing pazufloxacin mesilate quality method cannot separate photodegradable impurities, and comprises the following steps: (1) preparing a test solution; preparing a contrast solution; preparing a reference solution; (2) recording a chromatogram of a reference substance of the reference substance solution; (3) recording chromatograms of the test solution and the contrast solution; and (4) calculating the content of pazufloxacin mesylate by peak area according to an external standard method. According to the method, the proportion of the two mobile phases in the gradient is adjusted according to the polarity of each impurity, and isocratic elution is changed into gradient elution, so that the impurities with different polarities are well separated.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a quality control method for pazufloxacin mesylate injection. Background technique [0002] Pazufloxacin Mesylate Sodium Chloride Injection is widely used clinically. It is a large volume injection and belongs to the quinolone antibacterial drug. The main component is Pazufloxacin Mesylate, which has the characteristics of broad antibacterial spectrum and strong antibacterial effect. [0003] Pazufloxacin will degrade under light conditions, and should be kept away from light during storage. Document "Determination of Pazufloxacin Mesylate Sodium Chloride Injection Content and Related Substances by High Performance Liquid Chromatography" Pan Xigui, Wang Yang, Zhang Xianzhou and others reported that Pazufloxacin Mesylate Sodium Chloride Injection is vulnerable to light In the process of storage under different conditions, the injection will have different degrees of discolo...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
Inventor 秦方云魏琳王琴秦雪谢鹏飞刘晓娟
Owner 四川美大康佳乐药业有限公司
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