Process for the preparation of dexmethyl phenidate hydrochloride
AssigneeHarman Finochem Limited
InventorsVijay Trimbak Kadam, Nareesh Saranapu, Santosh Uttamrao Chavan, Harpreet Singh Minhas, Gurpreet Singh Minhas
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Abstract
Disclosed herein a process for the preparation of highly pure dexmethylphenidate hydrochloride (Formula-I) which comprises the steps of neutralization of dl-threomethylphenidate hydrochloride to dl-threo methylphenidate; subsequent resolution of dl-threo methylphenidate using amino acid or its derivatives as chiral resolution agent to yield dexmethylphenidate salt; hydrolysis of the salt and further conversion of dexmethylphenidate into its hydrochloride salt.
Claims15
A process for the preparation of optically pure dexmethylphenidate hydrochloride of Formula-I,
- comprising:
- a) neutralizing dl-threo-methylphenidate hydrochloride with a base in the presence of an organic solvent to produce dl-threo-methylphenidate;
- b) resolving the dl-threo-methylphenidate with a chiral amino acid or a derivative thereof in the presence of an alcohol or ketone solvent to obtain an amino acid salt of dexmethylphenidate, wherein the chiral amino acid is selected from the group consisting of valine, leucine, isoleucine, L-phenylalanine, glutamic acid, aspartic acid, and combinations thereof;
- c) converting the amino acid salt of dexmethylphenidate into its free base in the presence of a base and an organic solvent;
- and
- d) converting the free base of dexmethylphenidate obtained in step (c) into its hydrochloride salt.
Dependencies are inferred from the claim text.