Enantiomeric separation of colchicine and lacosamide by nano-LC. Quantitative analysis in pharmaceutical formulations
| Autor: | Zhengjin Jiang, María Ángeles García, María Luisa Marina, Natalia Casado |
|---|---|
| Přispěvatelé: | Universidad de Alcalá. Departamento de Química Analítica, Química Física e Ingeniería Química |
| Rok vydání: | 2020 |
| Předmět: |
chiral separation
lacosamide nano-LC Resolution (mass spectrometry) Lacosamide Antiepileptic drug Filtration and Separation enantiomers Pharmaceutical formulation 01 natural sciences colchicine Analytical Chemistry lcsh:Chemistry chemistry.chemical_compound Capillary column medicine Colchicine quality control Chromatography 010405 organic chemistry Chemistry 010401 analytical chemistry Química drug analysis lcsh:QC1-999 0104 chemical sciences lcsh:QD1-999 pharmaceutical formulation chiral impurities Enantiomer Quantitative analysis (chemistry) amylose-based stationary phase lcsh:Physics medicine.drug |
| Zdroj: | e_Buah Biblioteca Digital Universidad de Alcalá instname Separations, Vol 7, Iss 55, p 55 (2020) Separations Volume 7 Issue 4 |
| Popis: | A chiral analytical methodology was developed by nano-liquid chromatography (nano-LC) enabling the enantiomeric separation of two chiral drugs, lacosamide (novel antiepileptic drug) and colchicine (antiuremic drug), commercialized as pure enantiomers. A capillary column lab-packed with an amylose tris(3,5-dimethylphenylcarbamate) chiral stationary phase was used in a lab-assembled nano-LC system. Lacosamide and colchicine enantiomers were separated in less than 8.0 and 9.0 min, respectively, with resolution values of 1.6 and 2.3, using 20 nL of sample and 1.8 µ L of mobile phase per analysis. The analytical characteristics of the proposed methodology were evaluated according to the International Council for Harmonisation (ICH) guidelines, showing good analytical performance with good recoveries (97&ndash 98% and 100&ndash 103%) and precision values (relative standard deviation (RSD) < 10.5 and < 3.0%) for lacosamide and colchicine enantiomers, respectively. LODs were 1.7 and 2.0 µ g/mL for (S)- and (R)-lacosamide, respectively, and 1.0 µ g/mL for both colchicine enantiomers. Additionally, the developed methodology enabled to detect a 0.1% of the enantiomeric impurities, fulfilling the ICH regulation requirements. The method was applied to the determination of lacosamide and colchicine enantiomers in different pharmaceutical formulations to ensure their quality control. The content of the enantiomeric impurities was below a 0.1% and the amount of (R)-lacosamide and (S)-colchicine agreed with their labeled contents. |
| Databáze: | OpenAIRE |
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