<abstract xmlns="http://www.w3.org/1999/xhtml">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.The method offers a high throughput sample analysis, with an elution time of 2.9 minutes, and signal detection without excipient interference performed at 262 nm. The method proved to be linear between 1–15 µg mL−1 (<italic>R2</italic>= 0.9996). The mean recovery was found to be 98.7 ± 1.9 % in the tested range of 2.5–7.5 µg mL−1. Low RSD values (&lt; 1 %) were obtained for both model, intra- and inter-day precision. The limit of detection and limit of quantification were 0.24 and 0.78 µg mL−1, resp. The method proved to be applicable for active substance assay in a pharmaceutical dosage form.</abstract>

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.The method offers a high throughput sample analysis, with an elution time of 2.9 minutes, and signal detection without excipient interference performed at 262 nm. The method proved to be linear between 1–15 µg mL−1 (R2= 0.9996). The mean recovery was found to be 98.7 ± 1.9 % in the tested range of 2.5–7.5 µg mL−1. Low RSD values (< 1 %) were obtained for both model, intra- and inter-day precision. The limit of detection and limit of quantification were 0.24 and 0.78 µg mL−1, resp. The method proved to be applicable for active substance assay in a pharmaceutical dosage form.

HPLC method development for fampridine using Analytical Quality by Design approach

Department of Biochemistry and the Chemistry of Environmental Factors

Faculty of Pharmacy University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș

Department of General and Inorganic Chemistry, Faculty of Pharmacy

University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș

Department of Toxicology and Biopharmacy, Faculty of Pharmacy

Department of Pharmaceutical Industry and Management

Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș

Department of Pharmaceutical Chemistry, Faculty of Pharmacy

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in...

HPLC method development for fampridine using Analytical Quality by Design approach

Published Online: May 13, 2020

Page range: 465 - 482

Accepted: Nov 20, 2019

DOI: https://doi.org/10.2478/acph-2020-0036

Keywords
Analytical Quality by Design, fampridine, HPLC

© 2020 Béla Kovács et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

HPLC method development for fampridine using Analytical Quality by Design approach

Published Online: May 13, 2020

Page range: 465 - 482

Accepted: Nov 20, 2019

DOI: https://doi.org/10.2478/acph-2020-0036

KeywordsAnalytical Quality by Design, fampridine, HPLC

© 2020 Béla Kovács et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
Analytical Quality by Design, fampridine, HPLC