Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use

Background: The objective of this work was to study the vitamins B-1, B-2, B-6 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. Methods: The study was carried out during 72 h with formulations packaged in recommended storage temperature (4 degrees C) and 25 degrees C, with and without photoprotection. Results: The results showed that the methodologies used for assessing the chemical stability of vitamins B-1, B-2, B-6 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 degrees C. When stored at 25 degrees C vitamin C presented instability after 48 h. Conclusion: The 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 degrees C and 8 degrees C. This shelf life was measured considering the vitamins studied. Further studies are needed including all the vitamins present in this formulation.