Gradient - hplc for the simultaneous determination of the contaminants from a mixture of active ingredients from amino glycoside and glycopeptide

摘要

A process is described for qualitative and / or quantitative determination of the impurities in an active compound mixture of aminoglycoside and glycopeptide, which the separation of the components of the active compound mixture by means of a gradient - hplc, wherein the impurities of the glyco peptide by means of uv - detection and the impurities of the amino glycoside by electrochemical detection are determined, wherein the electrochemical detection downstream of the uv - detection is carried out, wherein between the uv - detection and of the electrochemical detection preferably an electrolytic solution is metered in in the eluate flow, and a suitable hplc - system. Preference is given to the aminoglycoside gentamicin sulfate and the glycopeptide vancomycin hydrochloride.The method is suitable for the quality control of a pharmaceutical or medical products which contain these active compound mixture.