A high-performance liquid chromatography method for analyzing bacitracin components

A high-performance liquid chromatography and bacitracin technology, which is applied in the field of high-performance liquid chromatography for analyzing bacitracin components, can solve the problems of poor separation effect of bacitracin and low column efficiency, and achieve easy promotion, high column efficiency and repeatability Good results

Active Publication Date: 2021-04-27
SHANGHAI INST FOR FOOD & DRUG CONTROL
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In order to solve the current pharmacopoeia ("European Pharmacopoeia" 9.0 edition, "British Pharmacopoeia" 2017 edition and "USP" 40 edition) and the literature in the poor separation effect of bacitracin, low column efficiency, etc., the present invention provides a simple, sensitive, Suitable HPLC method for bacitracin fractions

Method used

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  • A high-performance liquid chromatography method for analyzing bacitracin components
  • A high-performance liquid chromatography method for analyzing bacitracin components
  • A high-performance liquid chromatography method for analyzing bacitracin components

Examples

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Effect test

Embodiment 1

[0062] In this example, after dissolving bacitracin or bacitracin zinc, it is separated by a reversed-phase chromatographic column in an HPLC-UV system with ammonium formate-acetonitrile as the separation system, and each component is analyzed by an ultraviolet-visible light detector or a diode array detector Determination.

[0063] 1. Instruments and reagents

[0064] Agilent 1200 high-performance liquid chromatography (Agilent Corporation, USA).

[0065] USP bacitracin zinc reference substance (batch number: R048CO), EP bacitracin zinc reference substance (batch number: Batch3.0), and China Food and Drug Control Institute bacitracin reference substance (National Institute of Food and Drug Administration, batch number: 130320-200709).

[0066] 2. Experimental conditions

[0067] With 50mmol / L ammonium formate solution (adjust the pH value to 4.0 with formic acid) as mobile phase A, acetonitrile as mobile phase B, carry out the linear gradient elution procedure according to ...

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Abstract

The invention discloses a high-performance liquid chromatography (HPLC) method for analyzing bacitracin components. After dissolving bacitracin samples or bacitracin zinc samples in a solvent, each component directly passes through HPLC-UV through a reverse-phase chromatographic column Carry out analysis and determination; Wherein, mobile phase A is selected from ammonium formate solution, ammonium acetate solution, formic acid solution or acetic acid solution; Mobile phase B is selected from acetonitrile, methanol or organic solvent containing formic acid or acetic acid, eluted with gradient conditions, each group Analysis and determination are carried out by ultraviolet-visible light detectors, diode array detectors or mass spectrometer detectors. The method involved in the present invention is suitable for analyzing components in samples such as bacitracins such as raw materials, preparations, ointments, etc. Bacitracin A and bacitracin B1 / B2 / B3 are well separated from adjacent related substances , suitable for qualitative and quantitative analysis. The invention has the advantages of low cost, simple, efficient, fast and repeatable analysis process, and is convenient for quality control of products.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a high-performance liquid chromatography (HPLC) method for analyzing bacitracin components. Background technique [0002] Bacitracin (bacitracin, general structure see figure 1 ) is a mixture of a series of antimicrobial peptides produced by Bacillus subtilis and Bacillus licheniformis. Its antibacterial spectrum is similar to that of penicillin and can strongly inhibit Gram-positive bacteria. It is mainly used to treat penicillin-resistant staphylococcal infections. Bacitracin has a special antibacterial mechanism, which interferes with the synthesis of bacterial cell walls, and at the same time inhibits the regeneration of phospholipid receptors in the synthesis of peptidoglycan, making it have a broad antibacterial spectrum and is not easy to produce drug resistance. Zinc ions are added during medicinal use to enhance activity. [0003] Because it is a ferment...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/89G01N30/34G01N30/06G01N30/72G01N30/74G01N30/64G01N30/88
CPCG01N30/06G01N30/34G01N30/64G01N30/72G01N30/74G01N30/88G01N30/89G01N2030/8813
Inventor 张含智秦峰刘浩闻宏亮赵敬丹裘亚
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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