Drug Res (Stuttg) 2018; 68(11): 648-652
DOI: 10.1055/a-0635-8246
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

In-vitro Equilibrium Phosphate Binding Study of Sevelamer Carbonate by UV-Vis Spectrophotometry

Budi Prasaja
1   PT. Clinisindo Laboratories, Jakarta, Indonesia
,
M. Maulana Syabani
2   Division of Product Development, PT. Novell Pharmaceutical Laboratories, Jakarta, Indonesia
,
Endah Sari
2   Division of Product Development, PT. Novell Pharmaceutical Laboratories, Jakarta, Indonesia
,
Uci Chilmi
2   Division of Product Development, PT. Novell Pharmaceutical Laboratories, Jakarta, Indonesia
,
Prawitasari Cahyaningsih
2   Division of Product Development, PT. Novell Pharmaceutical Laboratories, Jakarta, Indonesia
,
Theresia Weliana Kosasih
2   Division of Product Development, PT. Novell Pharmaceutical Laboratories, Jakarta, Indonesia
› Author Affiliations
Further Information

Publication History

received 22 March 2018

accepted 22 May 2018

Publication Date:
12 June 2018 (online)

Abstract

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.

Supporting Information

 
  • References

  • 1 Llach F. Hyperphosphatemia in end-stage renal disease patients: pathophysiological consequences. Kidney Int Suppl 1999; 56: S31-S37
  • 2 Coladonato JA. Control of hyperphosphatemia among patients with ESRD. J Am Soc Nephrol 2005; 16 (Suppl. 02) S107-S114
  • 3 Quniby WY. Consequences of hyperphosphatemia in patients with end-stage renal disease (ESRD). Kidney Int Suppl 2004; 90: S8-S12
  • 4 Cozzolino M, Brancaccio D. Hyperphosphatemia and vascular calcification in chronic kidney disease. Therapy 2006; 3: 691-692
  • 5 Floege J, Ketteler M. Vascular calcification in patients with end-stage renal disease. Nephrol Dial Transplant 2004; 19 (Suppl. 05) v59-v66
  • 6 Saliba W, El-Haddad B. Secondary hyperparathyoridism: Pathophysiology and treatment. J Am Board Fam Med 2009; 22: 574-581
  • 7 Gunatillake ND, McQuarrie E, McKay G. . Sevelamer, Practical Diabetes 2014; 31: 349-350a
  • 8 Wrong O, Harland C. Sevelamer and other anion-exchange resins in the prevention and treatment of hyperphosphatemia in chronic renal failure. Nephron Physiol 2007; 107: 17-33
  • 9 Evenepoel P, Selgas R, Caputo F. et al. Efficacy and safety of sevelamer hydrochloride and calcium acetate in patients on peritoneal dialysis. Nephrol Dial Transplant. 2009; 24: 278-285
  • 10 FDA. Draft Guidance on Sevelamer Carbonate, 2015;
  • 11 Swearingen RA, Chen X, Petersen JS. et al. Determination of the binding parameter constants of Renagel® capsules and tablets utilizing the Langmuir approximation at various pH by ion chromatography. J Pharm Biomed Anal 2002; 29: 195-201
  • 12 Swearingen RA, Zhorov E, Cohen A. et al. Determination of the binding parameter constant of Renagel capsules and tablets at pH 7 by high performance capillary electrophoresis. J Pharm Biomed Anal 2004; 35: 753-760
  • 13 Mazzeo JR, Peters RM, Hanus MR. et al. A phosphate binding assay for sevelamer hydrochloride by ion chromatography. J Pharm Biomed Anal 1999; 19: 911-915
  • 14 Yang Y, Mohammad A, Berendt RT. et al. Evaluation of the in vitro efficacy of sevelamer hydrochloride and sevelamer carbonate. J Pharm Sci 2016; 105: 864-875
  • 15 Vallapragada VV, Inti G, Kanyadhara A. et al. Comparison of binding parameter constants between sevelamer HCl tablets and Renagel tablets by a validated inductively coupled plasma-optical emission spectrometry (ICP-OES) method. Am J Anal Chem 2012; 3: 820-827
  • 16 American Public Health Association . Standard methods for the examination of water and waste water. Washington: 1992. pp 112-113
  • 17 CHMP Committee for medicinal products for human use . Guideline on bioanalytical method validation. London: EMA; 2011