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New Stability Indicating RP-Ultra Fast Liquid Chromatographic Method for the Determination of Perampanel–An Antiepileptic Drug


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1 Department of Pharmaceutical Analysis and Quality Assurance GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India
     

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A new RP-UFLC method has been developed and validated for the determination of Perampanel in its capsules using Shimadzu Model CBM-20A/20 Alite UFLC system (Shimadzu Co., Kyoto, Japan) equipped with SPD M20A prominence photodiode array detector on C8 (2) 100A (Luna) column (250 mm×4.60 mm i.d. 5μm particle size)maintained at room temperature. Mobile phase consisting of a mixture of water, acetonitrile and 0.1% acetic acid (50:50:0.1 v/v) was chosen with a flow rate of 1 mL/min (UV detection at 215nm) on isocratic mode. Perampanel obeys Beer-Lambert’s law over the concentration range 0.05–120 μg/mL with linear regression equation y=73084x+13800 (r2=0.9999). Forced degradation studies were performed and the method was validated as per ICH guidelines.

Keywords

Perampanel, RP-UFLC, Stability Indicating, Validation, ICH Guidelines.
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  • New Stability Indicating RP-Ultra Fast Liquid Chromatographic Method for the Determination of Perampanel–An Antiepileptic Drug

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Authors

Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Analysis and Quality Assurance GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India
Rajani Kaibada
Department of Pharmaceutical Analysis and Quality Assurance GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India
Mandula Srinivas
Department of Pharmaceutical Analysis and Quality Assurance GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India

Abstract


A new RP-UFLC method has been developed and validated for the determination of Perampanel in its capsules using Shimadzu Model CBM-20A/20 Alite UFLC system (Shimadzu Co., Kyoto, Japan) equipped with SPD M20A prominence photodiode array detector on C8 (2) 100A (Luna) column (250 mm×4.60 mm i.d. 5μm particle size)maintained at room temperature. Mobile phase consisting of a mixture of water, acetonitrile and 0.1% acetic acid (50:50:0.1 v/v) was chosen with a flow rate of 1 mL/min (UV detection at 215nm) on isocratic mode. Perampanel obeys Beer-Lambert’s law over the concentration range 0.05–120 μg/mL with linear regression equation y=73084x+13800 (r2=0.9999). Forced degradation studies were performed and the method was validated as per ICH guidelines.

Keywords


Perampanel, RP-UFLC, Stability Indicating, Validation, ICH Guidelines.

References