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D. Rosenbaum, S. Holmes-Farley, W. Mandeville, M. Pitruzello and D. Goldberg, “Effect of Renagel, a Non- Abosrbable, Cross-Linked, Polymeric Phosphate Binder, on Urinary Phosphorus Excretion in Rats,” Nephrology Dialysis Transplantation, Vol. 12, No. 5, 1997, pp. 961- 964. doi:10.1093/ndt/12.5.961

has been cited by the following article:

• TITLE: Comparison of Binding Parameter Constants between Sevelamer HCl Tablets and Renagel Tablets by a Validated Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) Method

  AUTHORS: Venkata Vivekanand Vallapragada, Gopichand Inti, Ajay Kanyadhara, Sudhakar Rao Vidiyala, Sreeramulu Jadi

  KEYWORDS: Binding Parameter Constants; ICP-OES; In-Vitro Phosphate Binding Study; Langmuir Approximation; Renagel Tablets; Quantitation

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.3 No.12, December 25, 2012

  ABSTRACT: Sevelamer Hydrochloride is a crossolinked polymeric amine; it is the active ingredient in Renagel Tablets. Sevelamer Hydrochloride is indicated for the control of hyperphosphatamiea in patients with end-stage renal disease. The binding parameter constants of Sevelamer Hydrochloride were determined using the Langmuir approximation for the dosage form at pH 4.0 and 7.0 by Inductively Coupled Plasma-Optical Emission Spectrometry. An ICP-OES method has been developed to estimate free phosphate in In-Vitro phosphate binding study of Sevelamer HCl 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 for the range of concentrations 0.2 - 25.0 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 HCl Tablets.