Research Journal of Pharmacy and Technology

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Development and Validation of a New Stability Indicating Rp-uflc Method for the Estimation of Perampanel in Presence of Internal Standard


Affiliations
1 Department of Pharmaceutical Analysis, Gandhi Institute of Tecnology and Management ( Deemed to be University) GITAM Institute of Pharmacy, Vishakapatnam, Andhra Pradesh -530045, India
     

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Perampanel is chemically α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist. Perampanel is used for the treatment of seizures which involve one part of brain both in adults as well as in children who are above four years. In the present study a new stability indicating reverse phase ultrafast liquid chromatographic method has been proposed for the quantification of Perampanel in presence of an internal standard, Rufinamide using water: acetonitrile as mobile phase. Linearity was observed over the concentration range 0.05-50 μg/mL with linear regression equation y = 1.3839x - 0.0302 (r2 = 0.9999). The LOD and LOQ were found to be 0.01451 μg/mL and 0.0437 μg/mL. Perampanel was exposed to different stress conditions such as acidic hydrolysis, alkaline hydrolysis, oxidation and thermal treatment and the proposed method was validated.

Keywords

Stability indicating, Perampanel, Validation, UFLC, ICH guidelines.
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  • Development and Validation of a New Stability Indicating Rp-uflc Method for the Estimation of Perampanel in Presence of Internal Standard

Abstract Views: 137  |  PDF Views: 0

Authors

N S Yamani
Department of Pharmaceutical Analysis, Gandhi Institute of Tecnology and Management ( Deemed to be University) GITAM Institute of Pharmacy, Vishakapatnam, Andhra Pradesh -530045, India
Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Analysis, Gandhi Institute of Tecnology and Management ( Deemed to be University) GITAM Institute of Pharmacy, Vishakapatnam, Andhra Pradesh -530045, India

Abstract


Perampanel is chemically α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptor antagonist. Perampanel is used for the treatment of seizures which involve one part of brain both in adults as well as in children who are above four years. In the present study a new stability indicating reverse phase ultrafast liquid chromatographic method has been proposed for the quantification of Perampanel in presence of an internal standard, Rufinamide using water: acetonitrile as mobile phase. Linearity was observed over the concentration range 0.05-50 μg/mL with linear regression equation y = 1.3839x - 0.0302 (r2 = 0.9999). The LOD and LOQ were found to be 0.01451 μg/mL and 0.0437 μg/mL. Perampanel was exposed to different stress conditions such as acidic hydrolysis, alkaline hydrolysis, oxidation and thermal treatment and the proposed method was validated.

Keywords


Stability indicating, Perampanel, Validation, UFLC, ICH guidelines.

References