PROCESS FOR THE PREPARATION OF l-NOREPINEPHRINE BITARTRATE MONOHYDRATE HAVING HIGH ENANTIOMERIC PURITY
AssigneeHarman Finochem Limited
InventorsVijay Trimbak KADAM, Nareesh SARANAPU, Amin Rashid SHAIKH, Harpreet Singh MINHAS, Gurpreet Singh MINHAS
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Abstract
The present invention, discloses optically pure compounds of l-Norepinephrine and its acid addition salts and hydrates and process for the preparation thereof. Specifically, the present invention discloses optically pure compounds of l-Norepinephrine bitartrate, its process of preparation and pharmaceutical compositions comprising the same.
Claims9
A process for the preparation of optically pure l-Norepinephrine bitartrate monohydrate, wherein the process comprises;
- a) treating dl-Norepinephrine base with D-(−)-tartaric acid in the presence of water and an organic solvent to obtain crude l-Norepinephrine bitartrate;
- b) converting the l-Norepinephrine bitartrate obtained in step (a) into l-Norepinephrine base;
- c) treating the l-Norepinephrine base obtained in step (b) with L-(+)-tartaric acid and water to obtain l-Norepinephrine Bitartrate monohydrate having an optical purity of greater than 99%.
A process for the preparation of optically pure l-Norepinephrine bitartrate monohydrate, wherein the process comprises;
- a) treating dl-Norepinephrine base with D-(−)-tartaric acid in the presence of water and an organic solvent to obtain crude l-Norepinephrine bitartrate;
- b) converting the l-Norepinephrine bitartrate obtained in step (a) into l-Norepinephrine base by performing:
- a first step of converting the l-Norepinephrine bitartrate obtained in step (a) into l-Norepinephrine base;
- a second step of treating the l-Norepinephrine base obtained in the first step with D-(−)-tartaric acid to obtain pure l-Norepinephrine bitartrate;
- and
- a third step of converting the l-Norepinephrine bitartrate obtained in the second step into l-Norepinephrine base by treating with aqueous ammonia;
- and
- c) treating the l-Norepinephrine base obtained in the third step with L-(+)-tartaric acid and water to obtain l-Norepinephrine Bitartrate monohydrate having an optical purity of greater than 99%.
Dependencies are inferred from the claim text.