"Determination by Chromatographic Methods of Degradation Products of Thiamine 100mg Injection"

Abstract

is an essential nutrient that is involved in many physiological activities in the human body, including energy metabolism; synthesis of several ABSTRACT Injectable solution of Thiamine is a pharmaceutical prepared that participated in many chemical reactions of the body and is very use in vitamin and nutritional preparations. B 1 is a hydrosoluble (water-soluble) vitamin very sensitive to light, temperature, and oxidation increasing significantly its kinetic degradation when it is under exposure of those physic-chemical agents. Different studies of stability evidence that after 12 months the solution take a yellow light coloration, that intensify with the time, nonfulfillment the quality specifications as for organoleptic characteristics during the 24 months of validity. To improve the quality a redraw of formulation was done, changing the microbial preserver from Phenol to Chlorobutanol. Using different analytical techniques Thiamine storage stability in solution was monitored over time to determine the effect of different degradation agents like HCl, NaOH, H 2 O 2 , and thermolisis and photolysis. Degrading agents that more affect the used samples were NaOH and thermolisis.