HPLC method development for fampridine using Analytical Quality by Design approach
| Autor: | Blanka Székely-Szentmiklósi, Ibolya Fülöp, Béla Kovács, Éva Katalin Kelemen, Boglárka Kovács-Deák, Francisc Boda, István Székely-Szentmiklósi |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Quality Control
Pharmaceutical Science Excipient hplc 030226 pharmacology & pharmacy 01 natural sciences High-performance liquid chromatography Quality by Design Dosage form Excipients 03 medical and health sciences Analytical Quality by Design fampridine HPLC 0302 clinical medicine Limit of Detection medicine Potassium Channel Blockers 4-Aminopyridine Hplc method Pharmaceutical industry Chromatography High Pressure Liquid Mathematics Pharmacology Detection limit Dosage Forms Chromatography analytical quality by design Elution 010401 analytical chemistry Linearity Reproducibility of Results Signal Processing Computer-Assisted General Medicine 0104 chemical sciences Delayed-Action Preparations Drug Design Indicators and Reagents HD9665-9675 medicine.drug Tablets |
| Zdroj: | Acta Pharmaceutica Volume 70 Issue 4 Acta Pharmaceutica, Vol 70, Iss 4, Pp 465-482 (2020) |
| ISSN: | 1846-9558 1330-0075 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|