Stability Indicating Method for Determination of Sodium Picosulfate in Pharmaceutical Preparation – Comparison of HPLC, UHPLC and HTLC

Author(s): Petr Kastner*, Pavla Pilarova, Tomas Nejedly, Milos Machacek, Jiri Klimes

Journal Name: Current Pharmaceutical Analysis

Volume 13 , Issue 3 , 2017


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Abstract:

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 preparation.

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 lower.

Conclusion: Although all developed methods were satisfactorily validated, UHPLC is the most suitable technique for routine analysis or stability studies.

Keywords: Picosulfate, HPLC, UHPLC, HTLC, stability, preservatives.

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Article Details

VOLUME: 13
ISSUE: 3
Year: 2017
Published on: 05 April, 2017
Page: [250 - 255]
Pages: 6
DOI: 10.2174/1573412912666160518145632
Price: $65

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