High performance liquid chromatography method for analyzing bacitracin components

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...

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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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