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Vol. 32 No. 8 (2020): Vol 32 Issue 8, 2020

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

https://doi.org/10.14233/ajchem.2020.22669
Sathiyanarayanan Singaram
1 Department of Chemistry, Faculty of Science, Annamalai University, Annamalai Nagar-608002, India 2 Gland Pharma Ltd., Research and Development, D.P. Pally, Hyderabad-500043, India
Venkatesan Chidambaram Subramanian
Gland Pharma Ltd., Research and Development, D.P. Pally, Hyderabad-500043, India
Senthamaraikannan Kabilan
Department of Chemistry, Faculty of Science, Annamalai University, Annamalai Nagar-608002, India
Dandu Bhaskara Suresh Raju
Gland Pharma Ltd., Research and Development, D.P. Pally, Hyderabad-500043, India

Corresponding Author(s) : Sathiyanarayanan Singaram

ssnkmk1970@gmail.com

Asian Journal of Chemistry, Vol. 32 No. 8 (2020): Vol 32 Issue 8, 2020

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
Singaram, S. ., Subramanian, V. C. ., Kabilan, S. ., & Suresh Raju, D. B. . (2020). Identification, Synthesis, Characterization and Quality Control Strategy of New Process-Related Impurities in Fosphenytoin Sodium. Asian Journal of Chemistry, 32(8), 1881–1885. https://doi.org/10.14233/ajchem.2020.22669
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