Sorafenib dimethyl sulphoxide solvate
AssigneeRanbaxy Laboratories Limited
InventorsJagdev Singh Jaryal, Swargam Sathyanarayana, Rajesh Kumar Thaper, Mohan Prasad, Sachin Deorao Zade, Ajay Shankar Singh
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Abstract
The present invention provides dimethyl sulphoxide solvate of 4-(4-{3-[4-chloro-3 -(trifluoromethyl)phenyl]ureido}phenoxy)-N2-methylpyridine-2-carboxamide, process for its preparation, pharmaceutical composition comprising it and its use for the treatment of cancer. The present invention also provides a novel HPLC method for the identification, quantification and isolation of related substances of sorafenib.
Claims12
Sorafenib dimethyl sulphoxide solvate of Formula III
- characterized by X-ray diffraction peaks at d-spacing 5.20, 4.21, 4.16, 3.83 and 3.66 Å.
Sorafenib dimethyl sulphoxide solvate of Formula III characterized by X-ray diffraction pattern as depicted in FIG. 1.
Sorafenib dimethyl sulphoxide solvate of Formula III characterized by DSC thermogram having endotherms at about 123.69° C. and about 202.54° C.
Sorafenib dimethyl sulphoxide solvate of Formula III characterized by DSC thermogram as depicted in FIG. 2.
Sorafenib dimethyl sulphoxide solvate of Formula III characterized by X-ray diffraction pattern as depicted in FIG. 1 and DSC thermogram as depicted in FIG. 2.
Sorafenib dimethyl sulphoxide solvate of Formula III characterized by TGA as depicted in FIG. 3.
Sorafenib dimethyl sulphoxide solvate of Formula III characterized by IR spectrum as depicted in FIG. 4.
Sorafenib dimethyl sulphoxide solvate of Formula III having purity greater than 99% by HPLC.
A process for the preparation of sorafenib dimethyl sulphoxide solvate of Formula III
- comprising contacting sorafenib free base of Formula I
- with dimethyl sulphoxide.
Dependencies are inferred from the claim text.