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Abstract

Isolation and characterization of a process impurity in tizanidine hydrochloride

Author(s): E. K. S. Vijayakumar1, VG Gore1, A Mahajan2, M Kumar3
1 Mylan India Pvt. Ltd., Plot 1A/2, M.I.D.C. Industrial Estate, Taloja - 410 208, India 2 USV Limited, Govandi, Mumbai-400 088, India 3 Astrix Laboratories Ltd., Gaddapotharam, Kazipally Industrial Area, Medak Dist-502319, Andhra Pradesh, India

Correspondence Address:
E. K. S. Vijayakumar Mylan India Pvt. Ltd., Plot 1A/2, M.I.D.C. Industrial Estate, Taloja - 410 208 India E-mail: [email protected]


A new process impurity was detected during the HPLC analysis of Tizanidine hydrochloride (I) batches. The impurity (II) was isolated by preparative HPLC and characterized by NMR and Mass spectral analysis as 5-S-ethyl-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride.

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