Multivariate Analysis of Perampanel in Pharmaceutical Formulations Using RP-HPLC

A new, sensitive, robust RP-HPLC method was developed using quality by design (QbD) approach for the determination of perampanel in pharmaceutical tablets. Screening of five independent factors; concentration and pH of the phosphate buffer, temperature, flow rate and % of the aqueous part of mobile phase; was performed by a fractional factorial design (FFD). Optimization of the significant variables was achieved numerically and graphically using response surface methodology. The Analysis was achieved on Hypersil BDS C18 (150 × 4.6 mm, 5 μm) column applying an isocratic mobile phase containing acetonitrile and phosphate buffer pH 3.9 (55.7:44.3; v/v) at 1.4 mL/min flow rate and an injection volume of 10 μL. The analyte was detected at 210 nm. The proposed method was validated according to ICH guidelines. A linear range of 5–200 μg/mL was obtained with a high correlation coefficient (R2 = 0.9999). The accuracy of the method ranged from 97.92 to 100.60% and the RSD was less than 1.5. The developed method was robust and showed high predictability.