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US 2022/0064102 A1Published application
Process for preparation of highly pure fingolimod hydrochloride
AssigneeShivalik Rasayan Limited
InventorsAKSHAY KANT CHATURVEDI, VIMAL KUMAR SHRAWAT, SAHDEV SINGH
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Abstract
The present invention provides process for preparation of highly pure Fingolimod hydrochloride (I), without involving the use of column chromatographic purification in the entire process. Fingolimod hydrochloride (I) obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.
Claims8
A process for the preparation of highly pure Fingolimod hydrochloride (I) comprising the steps of:
- a) selectively octanoylating the compound of formula (A) at temperature ranging between −10 to −20° C. in the presence of a lewis acid and an organic solvent to get enriched para substituted regioisomer;
- b) purifying the compound of formula (B) without involving any column chromatography;
- c) performing hydrogenation selectively of step b) compound of formula (B) to obtain the compound of formula (C);
- d) reacting the compound of formula (C) in the presence of alkali hydroxide and an organic solvent to get compound of formula (D);
- e) hydrochlorinating the compound of formula (D) in an organic solvent to get Fingolimod hydrochloride (I).
2 more elements
Dependencies are inferred from the claim text.