Identification, Synthesis, Characterization and Quality Control Strategy of New Process-Related Impurities in Fosphenytoin Sodium

Sathiyanarayanan Singaram1,2,*, Venkatesan Chidambaram Subramanian2, Senthamaraikannan Kabilan1 and Dandu Bhaskara Suresh Raju2

1Department of Chemistry, Faculty of Science, Annamalai University, Annamalai Nagar-608002, India

2Gland Pharma Ltd., Research and Development, D.P. Pally, Hyderabad-500043, India

*Corresponding author: E-mail: ssnkmk1970@gmail.com

Abstract

Fosphenytoin sodium is a water dissolvable phenytoin prodrug that is directed intravenously to convey phenytoin, conceivably more securely than intravenous phenytoin. It is most ordinarily utilized in the intense treatment of convulsive status epileptics. The examination of the procedure-related contaminants will not help exclusively to advance the process parameters yet additionally to create sensible analytical methods and set the quality standard for a quality control system in pharmaceutical manufacturing. During the production of fosphenytoin sodium, all the process-related impurities are controlled in every stage and three degradation impurities are managed in the final API as per USP monograph. Besides, five unknown and one known contaminants were detected by HPLC method. All these impurities were identified, synthesized, isolated and characterized by IR, 1D-NMR (1H, 13C, DEPT) and HRMS spectral techniques. The mechanism of the formed impurities is examined for the first time. Quality control procedures to manage these impurities were developed to acquire the mass medication of ICH grade quality.

Keywords

Fosphenytoin sodium, Process related impurities.

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