Process for Preparation of Chlorpromazine or its Pharmaceutically Acceptable Salts
AssigneeSolara Active Pharma Sciences Limited
InventorsSankar Arjunan, Senthilnathan Palanivel, Aramanai Lakshmanan Srinivasan, Thirumalai Adhimoolam, Devendra Prasad Krishnan, Uttam Kumar Ray, Tangirala Vittal
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Abstract
Provided herein is a process for the preparation of Chlorpromazine or its pharmaceutically acceptable salts, preferably process for the preparation of Chlorpromazine or its pharmaceutically acceptable salts thereof having high purity.
Claims16
1) A process for the preparation of Chlorpromazine of formula I or a pharmaceutically acceptable salt thereof
- said process comprising reacting 2-chlorophenothiazine compound of formula II with a compound of formula III wherein X is selected from H, Cl, Br, or I
- in the presence of base in a biphasic medium to obtain the compound of formula I.
4) A process for purification of Chlorpromazine hydrochloride of formula Ia
- said process comprising the steps of:
- (i) providing a solution of Chlorpromazine hydrochloride of formula Ia in one or more organic solvents;
- (ii) optionally concentrating the solution obtained in step (i) under reduced pressure;
- (iii) adding an ester solvent to the solution or suspension obtained in step (i) or (ii);
- (iv) optionally cooling after step (iii);
- and
- (v) isolating the Chlorpromazine hydrochloride of formula Ia from the solution or suspension obtained in step (iii) or (iv).
7) A process for the preparation of Chlorpromazine hydrochloride compound of formula Ia having less than 0.05% w/w of dimeric impurities of formula IVa or IVb,
- said process comprising the steps of:
- (i) reacting 2-chlorophenothiazine compound of formula II with 3-dimethylaminopropylchloride compound of formula IIIa
- in the presence of base in biphasic medium to obtain Chlorpromazine;
- (ii) providing a solution of Chlorpromazine in one or more organic solvents;
- (iii) adding alcoholic hydrochloric acid to the solution obtained in step (ii);
- (iv) isolating the Chlorpromazine hydrochloride of formula Ia from the solution obtained in step (iii);
- and
- (v) optionally purifying the Chlorpromazine hydrochloride with one or more organic solvents.
13) A process for preparation of compound of formula Ic
- wherein R1 and R2 is selected from H or CH3;
- R3 is selected from H, Cl, Br, CF3, CH3 or OCH3;
- R4 is selected from substituted or unsubstituted C1-C4 alkyl;
- and X is selected from H, Cl, Br, or I
- said process comprising the step of:
- a) reacting a compound of formula IIa wherein R3 is selected from H, Cl, Br, CF3, CH3 or OCH3
- with a compound of formula IIIb wherein R1 and R2 is selected from H or CH3;
- R4 is selected from substituted or unsubstituted C1-C4 alkyl;
- and X is selected from H, Cl, Br, and I
- in the presence of base in a biphasic medium to obtain a compound of formula Ib;
- and
- b) converting the compound of formula 1b to the compound of formula Ic.
Dependencies are inferred from the claim text.