Chromatographic purification of vancomycin hydrochloride by...

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 9/00 (2006.01) C07K 1/20 (2006.01) A61K 38/00 (2006.01) G01N 30/02 (2006.01)

Patent

CA 2210987

The present invention discloses a new method for the purification of vancomycin hydrochloride by preparative HPLC (method of displacement chromatography), whereby the chromatographic purity of the product is essentially improved. The chromatography is performed on a reverse stationary phase with a mobile phase consisting of an organic or inorganic acid or of a buffer with possible additives, with different displacing agents, at a defined pH and temperature as well as the amount and concentration of vancomycin hydrochloride. The process is distinguished by the excellent yield and exceptional chromatographic purity 95.5 % area of the obtained product and, besides, it represents an ecologically irreproachable process. The vancomycin hydrochloride purified according to the present invention is useful for all types of application since the portion of impurities it contains is for one third lower than in hitherto known commercially available products.

Nouveau procédé de purification du chlorhydrate de vancomycine par la chromatographie liquide à haute performance (CLHP) de préparation (procédé de chromatographie par déplacement), afin d'obtenir un produit ayant une pureté chromatographique essentiellement améliorée. La chromatographie s'effectue sur une phase stationnaire inverse avec une phase mobile constituée d'un acide organique ou minéral ou d'un tampon avec d'éventuels additifs et avec différents agents de déplacement, le pH et la température étant déterminés, tout comme la quantité et la concentration du chlorhydrate de vancomycine. Ce procédé est caractérisé par le rendement excellent et la pureté chromatographique exceptionnelle (95,5 %) du produit obtenu. De plus, ce procédé est irréprochable sur le plan écologique. Le chlorhydrate de vancomycine purifié selon ce procédé convient à toutes les applications car sa teneur en impuretés est inférieure d'un tiers à celle des produits connus jusqu'à présent et disponibles dans le commerce.

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