Abstract
BackgroundThe objective of this work was to study the vitamins B1, B2, B6 and C stability in a pediatric formulation containing high amounts of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulfate, pediatric vitamins and trace elements under different conditions using developed and validated analytical methods.MethodsThe study was carried out during 72 h with formulations packaged in recommended storage temperature (4°C) and 25°C, with and without photoprotection.ResultsThe results showed that the methodologies used for assessing the chemical stability of vitamins B1, B2, B6 and C in the formulation were selective, linear, precise and accurate. The vitamins could be considered stable in the formulation during the three days of study if stored at 4°C. When stored at 25°C vitamin C presented instability after 48 h.ConclusionThe pediatric formulation containing high amount of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulphate, pediatric vitamins and trace elements packaged in bag-type trilaminate presented a shelf life of the 72 h, when maintained under refrigeration, between 2°C and 8°C. This shelf life was measured considering the vitamins studied. Further studies are needed including all the vitamins present in this formulation.
Highlights
The objective of this work was to study the vitamins B1, B2, B6 and C stability in a pediatric formulation containing high amounts of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulfate, pediatric vitamins and trace elements under different conditions using developed and validated analytical methods
The selectivity of vitamins B1 and B6 assay was determined by comparing the chromatograms obtained from placebo, spiked parenteral nutrition (PN) with titration of PN samples containing vitamin C, values between 5.0 and 16 mL
The precision was determined by the relative standard deviation (RSD) between the values obtained with the spiked samples with standard vitamins
Summary
The objective of this work was to study the vitamins B1, B2, B6 and C stability in a pediatric formulation containing high amounts of calcium in the presence of organic phosphate, amino acids, glucose, sodium chloride, magnesium sulfate, pediatric vitamins and trace elements under different conditions using developed and validated analytical methods. The first step of its degradation route, The main route of degradation of the thiamine is caused by its reduction due to the presence of sodium metabisulfite, the antioxidant used in the amino acid crystalline solutions [4,7,11,16,17,18], concentrations of 1 mmlo/ L, which are sufficient to promote degradation [6]. Riboflavin is one of the vitamins that present more sensibility to photodegradation [7,19]. It is irreversibly converted in luminoflavin, luminochromo and compounds of less importance in the presence of oxygen [3,4]
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