Background: Various chromatographic modes were used for the evaluation of liquid pharmaceutical
preparation containing favorite laxative drug sodium picosulfate.
Objective: The aim of this study was to compare capabilities of conventional HPLC, UHPLC and HTLC
on the example of stability indicating methods with UV 263 nm detection for simultaneous determination
of sodium picosulfate, its two degradation products and sodium benzoate in oral liquid pharmaceutical
Method: A novel money-saving preparation of system suitability test solution using partial acid hydrolysis
yielding main degradation products was developed. Developed HPLC system with RP-C18e column
used acetonitrile – propan-2-ol - phosphate puffer pH 7.0 with addition of cetyltrimethylammonium bromide
(43:2:55, v/v/v) as mobile phase, 1 ml/min, column temperature 40 °C. UHPLC separation was
carried out using core-shell RP-C18 column under the same chromatographic conditions, flow-rate 0.5
ml/min. HTLC method used the same column as in UHPLC, mobile phase acetonitrile - 30 mM triethylamine
phosphate buffer pH 5.0 (10:90, v/v), flow-rate 0.5 ml/min and column temperature 100 °C.
Results: HPLC method was very reliable and robust but rather time consuming, whereas UHPLC brought
5times faster analysis with 10times lower solvent consumption. High temperature during HTLC separation
did not affect the stability of the tested compounds, and organic solvents consumption was 8times
Conclusion: Although all developed methods were satisfactorily validated, UHPLC is the most suitable
technique for routine analysis or stability studies.