TITLE:
Comparison of Binding Parameter Constants between Sevelamer Carbonate Tablets and Renvela Tablets by a Validated Ion Chromatography Method
AUTHORS:
Venkata Vivekanand Vallapragada, Gopichand Inti, Sreenivas Reddy Geevanagari, Sudhakar Rao Vidiyala, Sreeramulu Jadi
KEYWORDS:
Binding Parameter Constants; Ion Chromatography; In-Vitro Phosphate Binding Study; Langmuir Approximation
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.4 No.5,
May
22,
2013
ABSTRACT: Sevelamer Carbonate is a crossolinked polymeric amine,
it is the active ingredient in Renvela Tablets. Sevelamer Carbonate
is indicated for the control of hyperphosphatamiea in patients with end-stage
renal disease. The binding parameter constants of Sevelamer Carbonate were
determined using the Langmuir approximation for the dosage form at pH 4.0 and
7.0 by Ion Chromatography. An Ion Chromatogrpahy method has been developed to
estimate free phosphate in in-vitro phosphate binding study of Sevelamer Carbonate Tablets. The method is selective
and capable of detecting phosphate in the presence of placebo matrix. The
method has been validated with a lower limit of quantitation of 0.2 mM for
Phosphate. A linear response function was established in the range of concentrations
0.2 - 30.0 mM (r > 0.99) for Phosphate. The intra and inter day
precision values for Phosphate met the acceptance as per Food and Drug Administrations
guidelines. Phosphate was stable in the set of stability studies viz. bench-top
and autosampler. The developed method was applied to in-vitro phosphate binding studies of Sevelamer Carbonate Tablets.