Acta Pharmaceutica (Dec 2020)

HPLC method development for fampridine using Analytical Quality by Design approach

  • Kovács Béla,
  • Boda Francisc,
  • Fülöp Ibolya,
  • Székely-Szentmiklósi István,
  • Kelemen Éva Katalin,
  • Kovács-Deák Boglárka,
  • Székely-Szentmiklósi Blanka

DOI
https://doi.org/10.2478/acph-2020-0036
Journal volume & issue
Vol. 70, no. 4
pp. 465 – 482

Abstract

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Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends. A new, experimental design-aided HPLC method for fampridine was developed and preliminarily validated according to current in-force international guidelines for linearity, accuracy, robustness and precision.

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