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

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.