Mixture of isomers of aminaphtone, analytical method for identifying them and pharmaceutical composition comprising said isomers
AssigneeLaboratori Baldacci SpA
InventorMassimo Baldacci
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Abstract
Provided are a mixture of positional isomers of aminaphtone, an aminaphtone product comprising the mixture and a new method of high-performance liquid chromatography (HPLC) useful for the characterization of aminaphtone. The method allows to identify in the positional isomers of which the aminaphtone in a product containing them and can be used to choose many aminaphtone mixtures suitable for pharmaceutical use.
Claims19
A mixture of positional isomers of aminaphtone consisting of 3-methyl-1,2,4-naphthalenetriol 2-(4-aminobenzoate) (isomer A) and of 3-methyl-1,2,4-naphthalenetriol 1-(4-aminobenzoate) (isomer B), characterized in that 3-methyl-1,2,4-naphthalenetriol 1-(4-aminobenzoate) (isomer B) is at least 95% by weight of said mixture.
A High-Performance Liquid Chromatography (HPLC) method for identifying the positional isomers of aminaphtone in a product containing them, wherein the method comprises the elution of said product with a mobile phase consisting of two solutions having different polarity, wherein said elution comprises an alternation of at least one isocratic phase and of at least one linear gradient phase, and wherein said elution comprises an alternation of isocratic and linear gradient phases, passing from more polar solutions to less polar solutions.
A pharmaceutical composition comprising a mixture of positional isomers A and B of aminaphtone, wherein isomer B is at least 95 wt % of said mixture, and at least one physiologically acceptable excipient.
A mixture of positional isomers of aminaphtone consisting of 3-methyl-1,2,4-naphthalenetriol 2-(4-aminobenzoate) (isomer A) and of 3-methyl-1,2,4-naphthalenetriol 1-(4-aminobenzoate) (isomer B), characterized in that 3-methyl-1,2,4-naphthalenetriol 1-(4-aminobenzoate) (isomer B) is at least 95% by weight of said mixture, wherein the isomer A and the isomer B are detected by a High-Performance Liquid Chromatography (HPLC) method for identifying the positional isomers of aminaphtone in a product containing them, wherein the method comprises the elution of said product with a mobile phase consisting of two solutions having different polarity, wherein said elution comprises an alternation of at least one isocratic phase and of at least one linear gradient phase, and wherein said elution comprises an alternation of isocratic and linear gradient phases, passing from more polar solutions to less polar solutions.
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