Acta Pharm. 70 (2020) 465-482

 

full paper

Original research paper

 

HPLC method development for fampridine using Analytical Quality by Design approach

BÉLA KOVÁCS, FRANCISC BODA, IBOLYA FÜLÖP, ISTVÁN SZÉKELY-SZENTMIKLÓSI, ÉVA KATALIN KELEMEN, BOGLÁRKA KOVÁCS-DEÁK and BLANKA SZÉKELY-SZENTMIKLÓSI

ibolya.fulop@umfst.ro

1 Gedeon Richter Romania, 540306 Tîrgu Mureș, Romania

2 Department of Biochemistry and the Chemistry of Environmental Factors, Faculty of Pharmacy University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș, 540139, Tîrgu Mureș, Romania

3 Department of General and Inorganic Chemistry, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș, 540139, Tîrgu Mureș, Romania

4 Department of Toxicology and Biopharmacy, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș, 540139, Tîrgu Mureș, Romania

5 Department of Pharmaceutical Industry and Management, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș, 540139, Tîrgu Mureș, Romania

6 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș, 540139, Tîrgu Mureș, Romania

Accepted November 20, 2019

Published online December 10, 2019

 

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.

 

Keywords: Analytical Quality by Design, fampridine, HPLC