Processes for the preparation of form i and form ii of palonosetron hydrochloride
AssigneeRanbaxy Laboratories Limited
InventorsGyanendra Pandey, Kaptan Singh, Surender Dhingra, Mohan Prasad, Tippasandra G. Chandrashekhar, Somenath Ganguly, Rita Santhakumar
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Abstract
The present invention relates to processes for the preparation of Form I and Form II of palonosetron hydrochloride. The present invention further relates to a method of determining the polymorphic forms of palonosetron hydrochloride using Fourier-Transform Infra-red (FTIR) method.
Claims14
A process for the preparation of the Form I of palonosetron hydrochloride, wherein said process comprises:
- a) treating palonosetron hydrochloride with a polar organic solvent and water, wherein the quantity of water is about 45% or more to the weight of palonosetron hydrochloride;
- and
- b) isolating the Form I of palonosetron hydrochloride from the mixture thereof.
A process for the preparation of the Form I of palonosetron hydrochloride, wherein the process comprises:
- a) dissolving palonosetron hydrochloride in water;
- b) removing the water from the solution obtained in step a);
- c) treating the residue obtained in step b) with a polar organic solvent substantially free of water at a temperature of about 25° C. or below;
- and
- d) isolating Form I of palonosetron hydrochloride from the mixture thereof.
A process for the preparation of the Form II of palonosetron hydrochloride, wherein the process comprises:
- a) dissolving palonosetron hydrochloride in a polar organic solvent;
- b) treating the solution obtained in step a) with a non-polar organic solvent;
- and
- c) isolating Form II of palonosetron hydrochloride from the mixture thereof.
A method of determining the polymorphic form of palonosetron hydrochloride, wherein the method comprises:
- a) generating an FTIR spectrum of a sample of palonosetron hydrochloride;
- and
- b) determining the polymorphic form of the sample by the ratio of intensity of the peaks at about 1456, about 1446, and about 1408 cm−1.
Dependencies are inferred from the claim text.