HPLC method development for fampridine using Analytical Quality by Design approach

Acta Pharmaceutica

Kovács-Deák Boglárka¹  Boda Francisc²  Székely-Szentmiklósi Blanka³  Fülöp Ibolya⁴  Kelemen Éva Katalin⁵  Székely-Szentmiklósi István⁵  Kovács Béla⁵ 

[1] 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;Department of General and Inorganic Chemistry, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș 540139, Tîrgu Mureș, Romania;Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș 540139, Tîrgu Mureș, Romania;Department of Toxicology and Biopharmacy, Faculty of Pharmacy, University of Medicine, Pharmacy, Science and Technology of Tîrgu Mureș 540139, Tîrgu Mureș, Romania;Gedeon Richter Romania, 540306Tîrgu Mureș, Romania;

关键词: analytical quality by design;    fampridine;    hplc;   

DOI  :  10.2478/acph-2020-0036

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown