HPLC Gradient Elution Method for Determination of Related Substances of Chlortetracycline Hydrochloride

Abstract

The invention relates to a method for determining related substances of aureomycin hydrochloride by an HPLC gradient elution method. Specifically, the method for the present invention's determination of related substances in aureomycin hydrochloride or its preparations comprises the steps: (1) high performance liquid chromatography and chromatographic column are provided; (2) mobile phase is prepared; (3) test solution is prepared (4) Inject various test solutions into the liquid chromatograph respectively, measure according to the specified chromatographic conditions, record the chromatogram and calculate the content of each related substance in the test substance. The method of the present invention exhibits one or more excellent effects as described in the specification, such as low column pressure, small chromatographic peak drift and / or stable test solution.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and relates to a method for detecting the quality of medicines, in particular to a method for determining related substances of the tetracycline antibiotic chlortetracycline. The present invention uses an HPLC gradient elution method to measure the related substances of chlortetracycline hydrochloride. The method exhibits one or more aspects of superior results. Background technique

[0002] Aureomycin (Chlortetracycline) is a golden yellow crystalline powder, which is produced by fermentation of Streptomyces aureofacieus. The fermentation broth is acidified and filtered to obtain a precipitate, which is dissolved in ethanol and then subjected to acid precipitation to obtain a crude product. Salt was hydrochloride crystallization. The effect and antibacterial spectrum of aureomycin are the same as those of tetracycline, its chemical formula: C22H23ClN2O8, molecular weight: 478.88, CAS registrat...

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