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

American Journal of Analytical Chemistry, 2012, 3, 820-827 /10.4236/ajac.2012.312108 Published Online December 2012 (http://www.SciRP.org/journal/ajac) Comparison of Binding Parameter Constants between Sevelamer HCl Tablets and Renagel Tablets by a Validated Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) Method Venkata Vivekanand Vallapragada , Gopichand Inti , Ajay Kanyadhara , 1,2* 1 1 1 2 Sudhakar Rao Vidiyala , Sreeramulu Jadi 1 Invagen Pharmaceutical Inc., Hauppauge, USA 2 Department of Chemistry, Sri Krishna Devaraya University, Anantapur, India * Email: vvviveka@ Received October 31, 2012; revised December 3, 2012; accepted December 10, 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 se- lective 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 con- centrations 0.2 - 25.0 mM (r 0.99) for Phosphate. The intra and inter day precision values for Phosphate met the ac- ceptance 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 phosphat