Multivariate Analysis of Perampanel in Pharmaceutical Formulations Using RP-HPLC
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ORIGINAL
Multivariate Analysis of Perampanel in Pharmaceutical Formulations Using RP‑HPLC Moussa M. Elhawi1 · Wafaa S. Hassan2 · Ragaa El‑Sheikh3 · Heba M. El‑Sayed2 Received: 28 February 2020 / Revised: 23 July 2020 / Accepted: 1 September 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
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. Keywords Film-coated tablets · HPLC–UV · Perampanel · Quality by design · Response surface methodology
Introduction Perampanel is an antiepileptic drug that is chemically 2-{6′-oxo-1′-Phenyl-1′,6′-dihydro-[2,3′-bipyridine]-5′-yl} benzonitrile (Fig. 1). Its antiepileptic action is due to the selective blocking of glutamate activity at the postsynaptic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptors with a noncompetitive mechanism [1]. It is used for the adjunctive treatment of primary generalized tonic–clonic seizures and partial-onset seizures with or without secondary generalization for patients 12 years or more in age [2]. Perampanel is taken orally as it is well absorbed from the gastrointestinal tract, and it has a high affinity (95%) to bind Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10337-020-03950-8) contains supplementary material, which is available to authorized users. * Heba M. El‑Sayed [email protected] 1
Exela Pharma Sciences LLC, Lenoir, NC 28645, USA
2
Analytical Chemistry Department, Faculty of Pharmacy, Zagazig University, Zagazig 44519, Egypt
3
Chemistry Department, Faculty of Science, Zagazig University, Zagazig 44519, Egypt
to plasma proteins and metabolized through CYP3A4- and CYP3A5 [3]. Few methods were reported for analysis of perampanel. HPLC methods were used for determination of perampanel in tablet formulation with UV detection [1], and in plasma with tandem mass spectrometry [4, 5], or UV detection [6]. International Conference on Harmonization (ICH) guidelines Q8(R2) describes quality by design (QbD) strategy and its principles as a systematic ap
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