Quantitative analysis of sodium picosulfate in the presence of its alkaline degradation product

Authors

  • Ivana Savić Department of Pharmaceutics, Faculty of Technology, Bulevar oslobodjenja 124, Leskovac
  • Goran Nikolić Department of Pharmaceutics, Faculty of Technology, Bulevar oslobodjenja 124, Leskovac
  • Ivan Savić Department of Pharmaceutics, Faculty of Technology, Bulevar oslobodjenja 124, Leskovac

DOI:

https://doi.org/10.20450/mjcce.2009.204

Keywords:

sodium picosulfate, alkaline degradation, HPLC, kinetics

Abstract

A new procedure for the analytical control of a pharmaceutical formulation by high performance liquid chromatographic (HPLC) is proposed. It allows the simultaneous determination of the major compounds in the formulation of the active compound (sodium picosulfate) and the degradation product (impurity), which slowly degrades by hydrolysis with different concentrations of sodium hydroxide, at different temperatures. Separation of sodium picosulfate from the degradation product was performed using the ZORBAX Eclipse XDB C-18 column, with a mobile phase consisting of phosphate buffer (pH = 7) : acetonitrile 85:15 v/v. The method was validated using the HPLC procedure, evaluating selectivity, accuracy, linearity and precision. The proposed method was successfully applied, with excellent recovery, to the analysis of a pharmaceutical formulation (Sodium picosulfate, Zdravlje-Actavis, Serbia) containing sodium picosulfate.

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Published

2009-12-15

How to Cite

Savić, I., Nikolić, G., & Savić, I. (2009). Quantitative analysis of sodium picosulfate in the presence of its alkaline degradation product. Macedonian Journal of Chemistry and Chemical Engineering, 28(2), 151–158. https://doi.org/10.20450/mjcce.2009.204

Issue

Vol. 28 No. 2 (2009)

Section

Analytical Chemistry

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