Process for the preparation of Pazopanib or a pharmaceutically acceptable salt thereof
AssigneeLaurus Labs Limited
InventorsSatyanarayana Chava, Seeta Rama Anjaneyulu Gorantla, Venkata Sunil Kumar Indukuri, Sanjay Kumar Dehury, Nagaraju Mekala, Jahangeer Baba Shaik, Durga Prasad Kuchipudi
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Abstract
The present invention is relates to an improved process for the preparation of pazopanib or a pharmaceutically acceptable salts thereof. The present invention also relates to novel polymorphic Forms of pazopanib hydrochloride, and its intermediates thereof.
Claims14
Crystalline Form-K1 of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine, characterized by a powder X-Ray diffraction (PXRD) pattern substantially in accordance with FIG. 22.
A process for preparation of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine Form-K1 characterized by a powder X-Ray diffraction (PXRD) pattern according to FIG. 22, comprising:
- a) reacting a compound of Formula II with methyl iodide in presence of potassium tert butoxide in dimethylformamide to obtain a compound of Formula III Form-K1,
- and
- b) isolating the Formula III Form-K1.
Crystalline Form-K2 of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine, characterized by a powder X-Ray diffraction (PXRD) pattern substantially in accordance with FIG. 23.
A process for preparation of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine Form-K2 characterized by a powder X-Ray diffraction (PXRD) pattern according to FIG. 23, comprising:
- a) reacting a compound of Formula II with methyl iodide in presence of potassium tert butoxide in tetrahydrofuran to obtain a compound of Formula III,
- b) concentrating the reaction mass to obtain a residue;
- c) adding water to the residue of step b);
- and
- d) isolating the Formula III Form-K2.
Crystalline Form-K3 of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine, characterized by a powder X-Ray diffraction (PXRD) pattern substantially in accordance with FIG. 24.
A process for preparation of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine Form-K3 characterized by a powder X-Ray diffraction (PXRD) pattern according to FIG. 24, comprising:
- a) reacting a compound of Formula II with methyl iodide in presence of potassium tert butoxide in acetonitrile to obtain a compound of Formula III,
- and
- b) isolating the Formula III Form-K3.
Crystalline Form-K4 of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine, characterized by a powder X-Ray diffraction (PXRD) pattern substantially in accordance with FIG. 25.
A process for preparation of N-(2-chloropyrimidin-4-yl)-N-2,3-trimethyl-2H-indazol-6-amine Form-K4 characterized by a powder X-Ray diffraction (PXRD) pattern according to FIG. 25, comprising:
- a) reacting compound of Formula II with methyl iodide in presence of potassium tert butoxide in dimethylsulfoxide to obtain a compound of Formula III,
- b) concentrating the reaction mass to obtain a residue;
- c) adding water to the residue of step b);
- and
- d) isolating the Formula III Form-K4.
Dependencies are inferred from the claim text.