HPLC method development for fampridine using Analytical Quality by Design approach.

HPLC method development for fampridine using Analytical Quality by Design approach. Acta Pharm. 2020 Dec 01;70(4):465-482 Authors: Kovács B, Boda F, Fülöp I, Székely-Szentmiklósi I, Kelemen ÉK, Kovács-Deák B, Székely-Szentmiklósi B 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. PMID: 32412430 [PubMed - as supplied by publisher]
Source: Acta Pharmaceutica - Category: Drugs & Pharmacology Authors: Tags: Acta Pharm Source Type: research