title: Chemical stability study of vitamins thiamine, riboflavin, pyridoxine and ascorbic acid in parenteral nutrition for neonatal use.
abstract: BACKGROUND
  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.
  
  
  METHODS
  The study was carried out during 72 h with formulations packaged in recommended storage temperature (4°C) and 25°C, with and without photoprotection.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  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°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.
authors.affiliation: Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, RJ 21941-590, Brazil.
authors.forename: Daniela O
authors.initials: DO
authors.lastname: Ribeiro
authors.forename: Daniela C
authors.initials: DC
authors.lastname: Pinto
authors.forename: Luis Mauricio T R
authors.initials: LM
authors.lastname: Lima
authors.forename: Nádia M
authors.initials: NM
authors.lastname: Volpato
authors.forename: Lúcio M
authors.initials: LM
authors.lastname: Cabral
authors.forename: Valéria P
authors.initials: VP
authors.lastname: de Sousa
mesh_terms: D000596:Amino Acids / Q000032:analysis; D001205:Ascorbic Acid / Q000032:analysis* / Q000378:metabolism; D002118:Calcium / Q000032:analysis; D005526:Food, Formulated / Q000032:analysis*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D010755:Organophosphates / Q000032:analysis / Q000378:metabolism; D018384:Oxidative Stress; D010288:Parenteral Nutrition; D011736:Pyridoxine / Q000032:analysis* / Q000378:metabolism; D012256:Riboflavin / Q000032:analysis* / Q000378:metabolism; D013831:Thiamine / Q000032:analysis* / Q000378:metabolism; D054928:Validation Studies as Topic; D014815:Vitamins / Q000032:analysis* / Q000378:metabolism
chemical_list: D000596:Amino Acids; D010755:Organophosphates; D014815:Vitamins; D011736:Pyridoxine; D001205:Ascorbic Acid; D002118:Calcium; D012256:Riboflavin; D013831:Thiamine