Development and Validation of a Stability-Indicating Hydrophilic Interaction Liquid Chromatographic Method for the Determination of Sulfaquinoxaline Sodium in Water Soluble Powder Formulation

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.