Development of a Stability Indicating Method for Simultaneous Analysis of Five Water-Soluble Vitamins by Liquid Chromatography
| Autor: | Lise Bernard, Valérie Sautou, Daniel Bourdeaux, Philip Chennell, Mouloud Yessaad |
|---|---|
| Přispěvatelé: | Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Laboratoire de Pharmacie Clinique et Biotechnique, Université d'Auvergne - Clermont-Ferrand I (UdA) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
analytical validation
Pharmacy RM1-950 030226 pharmacology & pharmacy 01 natural sciences 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Chromatography detector liquid chromatography [CHIM]Chemical Sciences Pharmacology (medical) diode array detector Hydrogen peroxide Acetonitrile Pharmaceutical industry Pharmacology water-soluble vitamins Chromatography Chemistry 010401 analytical chemistry Ascorbic acid 0104 chemical sciences Solvent B vitamins Forced degradation Water-Soluble Vitamin stability indicating method Therapeutics. Pharmacology HD9665-9675 |
| Zdroj: | Pharmaceutical Technology in Hospital Pharmacy Pharmaceutical Technology in Hospital Pharmacy, De Gruyter, 2018, 3 (4), pp.207-218. ⟨10.1515/pthp-2018-0026⟩ Pharmaceutical Technology in Hospital Pharmacy, 2018, 3 (4), pp.207-218. ⟨10.1515/pthp-2018-0026⟩ Pharmaceutical Technology in Hospital Pharmacy, Vol 3, Iss 4, Pp 207-218 (2018) |
| ISSN: | 2365-242X |
| Popis: | Background Water-soluble vitamins are often included simultaneously in pharmaceutical formulations as food complements or in parenteral nutrition mixtures. Given their sensitivity to heat, light or pH variations, it is important to study their stability using validated stability indicating methods. We thus aimed to validate a liquid chromatography (LC) stability-indicating method for the simultaneous quantification of 5 water-soluble vitamins. Methods We analyzed four water-soluble B vitamins (nicotinamide, pyridoxine, folic acid, cyanocobalamin) and ascorbic acid using a LC method with diode array detector. They were separated on a C18 stationary phase under gradient elution of solvent A [0.2 % of metaphosphoric acid in water and acetonitrile 98:2] and solvent B (100 % acetonitrile). All vitamins were subjected to forced degradation conditions and we showed that the obtained degradation products didn’t interfere with the vitamins. Results The method allows the separation of the 5 water-soluble vitamins in a 30 minute run without any interference from the breakdown products obtained with acid/alkaline solutions, hydrogen peroxide, temperature and light. It meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity. Conclusions This stability-indicating method can be used for carrying out stability studies of water-soluble vitamins in pharmaceutical preparations. |
| Databáze: | OpenAIRE |
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