AJAC  Vol.3 No.12 , December 2012
Comparison of Binding Parameter Constants between Sevelamer HCl Tablets and Renagel Tablets by a Validated Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) Method
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.
Cite this paper: V. Vallapragada, G. Inti, A. Kanyadhara, S. Vidiyala and S. Jadi, "Comparison of Binding Parameter Constants between Sevelamer HCl Tablets and Renagel Tablets by a Validated Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) Method," American Journal of Analytical Chemistry, Vol. 3 No. 12, 2012, pp. 820-827. doi: 10.4236/ajac.2012.312108.

[1]   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

[2]   G. Chertow, S. Burke and J. Lazarus, “Poly Allylamine Hydrochloride (Renagel): A Noncalcemic Phosphate Binder for the Treatment of Hyperphosphatemia in Chronic Renal Failure,” American Journal of Kidney Diseases, Vol. 27, No. 1, 1997, pp. 66-71. doi:10.1016/S0272-6386(97)90009-3

[3]   S. Burke, E. Slatopolsky and D. Goldberg, “Renagel, a Novel Calcium-and Aluminium-Free Phosphate Binder, Inhibits Phosphate Absorption in Normal Volunteers,” Nephrology Dialysis Transplantation, Vol. 12, No. 8, 1997, pp. 1640-1644. doi:10.1093/ndt/12.8.1640

[4]   R. A. Swearingen, X. Chen, J. S. Petersen, K. S. Riley, D. Wang and E. Zhorov, “Determination of the Binding Parameter Constants of Renagel Capsules and Tablets Utilizing the Langmuir Approximation at Various PH by Ion Chromatography,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 29, No. 1-2, 2002, pp. 195- 201. doi:10.1016/S0731-7085(02)00007-9

[5]   J. Mazzeo, R. Peters, M. Hanus, X. Chen and K. Norton, “A Phosphate Binding Assay for Sevelamer Hydrochloride by Ion Chromatography,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 19, No. 6, 1999, pp 911- 915. doi:10.1016/S0731-7085(98)00193-9

[6]   S. R. Holmes-Farley, W. H. Manderville and K. L. Miller, “Design and Characterization of Sevelamer Hydrochloride: A Novel Phosphate-Binding Pharmaceutical,” Journal of Macromolecular Science: Pure and Applied Chemistry, Vol. 36, No. 7-8, 1999, pp. 1085-1091.

[7]   G. M. Chertow, S. K. Burke, P. Raggi, et al., “Sevelamer Attenuates the Progression of Coronary and Aortic Calcification in Hemodialysis Patients,” Vol. 26, No. 1, 2002, pp. 245-252. doi:10.1046/j.1523-1755.2002.00434.x

[8]   A. C. Alfrey, G. R. LeGendre and W. D. Kaehny, “The Dialysis Encephalopathy Syndrome, Possilbe Aluminum Intoxication,” The New England Journal of Medicine, Vol. 294, No. 4, 1976, pp. 1184-1188. doi:10.1056/NEJM197601222940402

[9]   I. S. Parkinson, M. K. Ward and D. N. Kerr, “Dialyis Encephalopathy, Bone Disease and Anaemia: The Aluminum Intoxication Syndrome Duringregular Haemodialysis,” Journal of Clinical Pathology, Vol. 34, No. 11, 1981, pp. 1285-1294. doi:10.1136/jcp.34.11.1285

[10]   J. J. Plachot, G. Cournot-Witmer, S. Halpern, V. Mendes, A. Bourdeau, J. Fritsch, R. Bourdon, T. Drueke, P. Galle and S. Balsan, “Bone Ultrastructure and X-Ray Microanalysis of Alumimum-Intoxicated Hemodialyzed Patients,” Kidney International, Vol. 25, No. 5, 1984, pp. 796-803. doi:10.1038/ki.1984.92

[11]   H. H. Malluche and M. C. Monier-Faugere, “Risk of Adynamic Bone Disease in Dialyzed Patients,” Kidney International, Vol. 42, Suppl. 38, 1992, pp. S62-S67.

[12]   M. Touam, F. Martinez, B. Lacour, R. Bourdon, J. Zingraff, S. Di Giulio, T. Drueke, “Aluminium-Induced, Reversible Microcytic Anemia in Chronic Renal Failure: Clinical and Experimental Studies,” Clinical Nephrology, Vol. 19, No. 6, 1983, pp. 295-298.

[13]   M. Wallot, K. E. Bonzel, A. Winter, B. Georger, B. Lettgen and M. Bald, “Calcium Acetate versus Calcium Carbonate as Oral Phosphate Binder in Pediatric and Adolescent Hemodialysis Patients,” Pediatric Nephrology, Vol. 10, No. 5, 1996, pp. 625-630. doi:10.1007/s004670050175

[14]   W. G. Goodman, J. Goldin, B. D. Kuizon, B. Yoon Cm Gales, D. Sider, Y. Wang, J. Chung, A. Emerick, L. Greaser, R. M. Elashoff and I. B. Salusky, “Coronary- Artery Calcification in Young Adults with End-Stage Renal Disease who are Undergoing Dialysis,” The New England Journal of Medicine, Vol. 342, No. 20, 2000, pp. 1478-1483. doi:10.1056/NEJM200005183422003

[15]   J. A. Delmez, C. A. Tindira, D. W. Windus, K. Y. Norwood, K. S. Giles, T. L. Nighswander and E. Slatopolsky, “Calcium Acetate as a Phosphorus Binder in Hemodialysis Patients,” Journal of the American Society of Nephrology, Vol. 3, No. 1, 1992, pp. 96-102.

[16]   C. H. Hsu, “Are We Mismanaging Calcium and Phosphate Metabolism in Renal Failure?” American Journal of Kidney Diseases, Vol. 29, No. 4, 1997, pp. 641-649. doi:10.1016/S0272-6386(97)90352-8

[17]   G. Eknoyan, A. Levin and N. W. Levin “Bone Metabolism and Disease in Chronic Kidney Disease,” American Journal of Kidney Diseases, Vol. 42, No. 3, 2003, pp. S1- 201. doi:10.1016/S0272-6386(03)00905-3

[18]   W. Y. Qunibi, R. E. Hootkins, L. L. McDowell, M. S. Meyer, M. Simon, R. O. Garza, R. W. Pelham, M. V. Cleveland, L. R. Muenz, D. Y. He and C. R. Nolan, “Treatment of Hyperphosphatemia in Hemodialysis Patients: The Calcium Acetate Renagel Evaluation (CARE Study),” Kidney International, Vol. 65, No. 5, 2004. pp. 1914-1926. doi:10.1111/j.1523-1755.2004.00590.x

[19]   C. B. Boss and K. J. Fredeen, “Concepts, Instrumentation and Techniques in Inductively Coupled Plasma Optical Emission Spectrometry,” 3rd Edition, Perkin Elmer, Waltham, 1997.

[20]   P. W. J. M. Boumans, “Inductively Coupled Plasma Emission Spectroscopy-Part 2,” In: P. J. Elving and J. D. Winefordner, Eds., Chemical analysis, John Wiley & Sons, New York, Vol. 90, 1987.