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A new stability indicating HPLC method for related substances in zolmitriptan

Author(s): E. K. S. Vijayakumar, MA Samel, SB Bhalekar, SM Pakhale
Mylan India Pvt. Ltd., Plot 1A/2, M.I.D.C. Industrial Estate, Taloja, Panvel-410 208, India

Correspondence Address:
E. K. S. Vijayakumar Glenmark Pharmaceuticals Ltd., Mahape, Navi Mumbai - 400 709 India E-mail: [email protected]

A sensitive, precise, specific, linear and stability indicating isocratic HPLC method was developed for the analysis of related substances in zolmitriptan. The potential known related substances are (S)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one (impurity I) and (S)-4-(4-hydrazinobenzyl)-1,3-oxazolidin-2-one (impurity II). The method can be used for the detection and quantification of known and unknown impurities and degradants in the drug substance zolmitriptan during routine analysis and also for stability studies in view of its capability to separate degradation products.

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