US 5,853,720 AGranted

Combined process for the purification of vancomycin hydrochloride

AssigneeLEK, tovarna farmacevtskih in kemicnih izdelkov, d.d.

InventorsZlatko Pflaum, Robert Turkalj

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Abstract

The present invention discloses a new process for the purification of vancomycin hydrochloride by combining preparative chromatography on a silica gel column and the precipitation with ethanol from a salt-water-ethanolic solution without intermediary filtering, whereby the chromatographic purity of the product is improved. The chromatography is carried out on a column containing a silica gel stationary phase and an alkaline water-methanolic mobile phase at defined pH, mobile phase flow and temperature as well as the amount and concentration of vancomycin hydrochloride. The process is distinguished by the yield and chromatographic purity of the obtained product of about 93% area. Vancomycin hydrochloride purified according to the present invention is useful for peroral as well as parenteral administration since the portion of impurities it contains is for one third smaller than in hitherto available product.

Claims17

Dependent claims

A new process for the purification of vancomycin antibiotics, characterized in that it combined preparative chromatography on a silica gel column containing an alkaline water-methanolic mobile phase and precipitation with ethanol from a salt-water-ethanolic solution for side fractions, which comprises the following stages:

a) concentrating the acidified combined side fractions of the antibiotic having concentrations up to about 1.5 g/l by reverse osmosis;
b) addition of NaCl and stirring to achieve the dissolution of the salt and the crystallization of the antibiotic;
c) addition of ethanol to the resulting suspension at room temperature to cause first the dissolution of the crystallized antibiotic and a further addition of ethanol (totally four times more ethanol than water) to initiate the precipitation of the antibiotic;
d) the cooling of the obtained suspension to about 5.degree. C. and centrifugation;
e) desalting of the antibiotic in reverse osmosis and continuing the process as used for the main fraction.

2 more elements

Dependencies are inferred from the claim text.