Development and Validation of a Stability-Indicating Hydrophilic Interaction Liquid Chromatographic Method for the Determination of Sulfaquinoxaline Sodium in Water Soluble Powder Formulation
Date
2014-08-01
Authors
Ghanem, Mashhour
Abu-lafi, Saleh
Mohammad, Diyaa
Journal Title
Journal ISSN
Volume Title
Publisher
Academic Sciences
Abstract
Objective: This study aims to develop and validate a stability-indicating hydrophilic interaction liquid chromatographic method for the
determination of sulfaquinoxaline sodium (SQXS) in the presence of sulfaquinoxaline related compound A (SQXA) in a commercially available water
soluble powder formulation.
Methods: The analytes were separated on zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC) column with a solvent mixture of
200mM ammonium acetate (NH4AC) solution and acetonitrile (ACN) (10:90; v/v) at pH adjusted to 5.7 by glacial acetic acid. The mobile phase flow
was fixed at 0.5 ml/min and the analytes were monitored at 263nm at ambient temperature. Forced degradation experiments were carried out by
exposing sulfaquinoxaline sodium standard and the water soluble powder formulation for thermal, photolytic, oxidative and acid-base hydrolytic
stress conditions.
Results: The results showed that SQXA and the other degradation products were fully resolved from sulfaquinoxaline sodium and thus the proposed
ZIC-HILIC method is stability-indicating.
Conclusion: The method was validated as per ICH and USP guidelines and found to be adequate for routine quantitative determination of SQXS in
the presence of SQXA and other degradation impurities in commercially available water soluble powder dosage forms.
Description
Keywords
Validation , Stability-indicating method , Sulfaquinoxaline sodium , Sulfaquinoxaline related compound A , Water soluble powder