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Multivariate Analysis of Perampanel in Pharmaceutical Formulations Using RP-HPLC

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Abstract

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.

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Acknowledgements

The authors are grateful to Adwia Pharmaceuticals, 10th of Ramadan city, Cairo, Egypt, for providing laboratory facilities to carry out this work.

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Authors and Affiliations

  1. Exela Pharma Sciences LLC, Lenoir, NC, 28645, USA

    Moussa M. Elhawi

  2. Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt

    Wafaa S. Hassan & Heba M. El-Sayed

  3. Chemistry Department, Faculty of Science, Zagazig University, Zagazig, 44519, Egypt

    Ragaa El-Sheikh

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  1. Moussa M. Elhawi
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  2. Wafaa S. Hassan
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  3. Ragaa El-Sheikh
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  4. Heba M. El-Sayed
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Correspondence to Heba M. El-Sayed.

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Elhawi, M.M., Hassan, W.S., El-Sheikh, R. et al. Multivariate Analysis of Perampanel in Pharmaceutical Formulations Using RP-HPLC. Chromatographia 83, 1335–1343 (2020). https://doi.org/10.1007/s10337-020-03950-8

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