Sevelamer carbonate is a cross-linked polymeric amine; it is the active ingredient
in Renvela® tablets. US FDA provides recommendation for demonstrating bioequivalence for the
development of a generic product of sevelamer carbonte using in-vitro equilibrium
binding study. A simple UV-vis spectrophotometry method was developed and validated
for quantification of free phosphate to determine the binding parameter constant of
sevelamer. The method validation demonstrated the specificity, limit of quantification,
accuracy and precision of measurements. The validated method has been successfully
used to analyze samples in in-vitro equilibrium binding study for demonstrating bioequivalence.
Key words
biopharmaceuticals - chemistry - bioavailability - absorption
