Abstract
Abstract 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.
Highlights
Vitamins are a broad group of organic compounds required to maintain normal eukaryotic cellular and metabolic functions
*Corresponding author: Lise Bernard, University of Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, ICCF, F-63000 Clermont–Ferrand, France, E-mail: l_bernard@chu-clermontferrand.fr Mouloud Yessaad, University of Clermont Auvergne, CHU ClermontFerrand, CNRS, SIGMA Clermont, ICCF, F-63000 Clermont–Ferrand, France Daniel Bourdeaux, Service Pharmacie, Polyclinique La Pergola, 03205 Vichy, France Philip Chennell, Valérie Sautou, University of Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, ICCF, F-63000 Clermont–Ferrand, France http://orcid.org/0000-0001-8086-7517. This stability-indicating method can be used for carrying out stability studies of water-soluble vitamins in pharmaceutical preparations
Reagents used for forced degradations were sodium hydroxide concentrate (NaOH) (CAS number 1310–73-2, The analyses were performed using a Jasco 2000 liquid chromatographic system composed of a PU-2080 Plus pump, and an AS-2055Plus auto-sampler coupled with a diode array detector (MD −2018 Plus Jasco France, Bouguenais, France)
Summary
Vitamins are a broad group of organic compounds required to maintain normal eukaryotic cellular and metabolic functions. 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. 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
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