Emcure Pharmaceuticals Limited

Pravin Prabhakar Ahirrao

Mukund Keshav Gurjar

Samit Satish Mehta

Prasad Pandurang Panchabhai

Prabhakaran Balasubramanian

Narendra Kumar Tripathy

Neelakandan Kaliaperumal

Srinivas Nandala

Raghuramireddy Baireddy

Balaji R Mugale

Sandip B Buchude

Nandala Srinivas

Kaliaperumal Neelakandan

Balaji Ram Mugale

Sandip Bajaba Buchude

A process for preparation of diethyl 2-aetamido-2-(4-octyl phenyl)ethyl malonate (III), a key intermediate of fingolimod hydrochloride comprising reaction of 2-(4-octylphenyl)ethyl iodide (IV) with diethyl acetamido malonate in presence of a base and an iodinating agent and in an organic solvent. The compound of formula (III) thus obtained provided fingolimod hydrochloride (Ia) having associated impurities below the regulatory limits.

Fingolimod hydrochloride process

The present invention provides a convenient and industrially viable process for preparation of Zolmitriptan (I) having desired purity. The invention specifically relates to a method for isolating (S)-4-(4-hydrazinobenzyl)-1,3-oxazolidin-2-one hydrochloride (IIIa) of desired purity by separating the undesired inorganic side products such as stannous hydroxide by manipulation of pH at different stages and finally treating with N,N-dimethylamino butyraldehyde diethyl acetal in an acidic medium to provide Zolmitriptan (I) conforming to regulatory specifications.

Process for preparation of zolmitriptan

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Pune, India

Pravin Prabhakar Ahirrao