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 improved quality control, low cost, and repeated good sex effect
Active Publication Date: 2019-03-08
SHANGHAI INST FOR FOOD & DRUG CONTROL
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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
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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] Use 50mmol / L ammonium formate solution (adjust the pH value to 4.0 with formic acid) as mobile phase A, acetonitrile as mobile phase B, and elute according to the following linear gradient at a flow...
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Abstract
The invention discloses a high performance liquid chromatography (HPLC) method for analyzing bacitracin components. The method comprises the following steps: dissolving a bacitracin sample or a bacitracin zinc sample in a solvent, and directly analyzing and determining various components by HPLC-UV by virtue of a reversed phase column, wherein a mobile phase A is selected from an ammonium formatesolution, an ammonium acetate solution, a formic acid solution or an acetic acid solution; a mobile phase B is selected from acetonitrile, methanol or an organic solvent containing formic acid or acetic acid; and by virtue of gradient condition elution, the various components are analyzed and determined by an ultraviolet-visible detector, a diode array detector or a mass spectrometry detector. Themethod disclosed by the invention is applied to analyzing components in bacitracin samples such as bulk pharmaceutical chemicals, preparations and ointments, excellent separation is realized betweenbacitracin A and bacitracin B1 / B2 / B3 and adjacent related substances, and the method is applicable to qualitative and quantitative analysis. The method disclosed by the invention has the advantages ofbeing low in cost, simple and effective in analysis process, rapid, excellent in repeatability and the like, and is conveniently used for product quality control.
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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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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