Development of a Unified Extraction Approach for the Simultaneous Determination of a Novel Antibacterial Drug (ZAB260) and Parabens by Reverse-Phase High-Performance Liquid Chromatography

This study aims to develop a robust and accurate analytical method for ZAB260, a novel bacterial topoisomerase inhibitor (NBTI), and parabens (methyl paraben and propyl paraben) in cream matrices, which is critical for ensuring comprehensive quality control and effective monitoring. ZAB260, a potent antibacterial agent targeting DNA gyrase and topoisomerase IV, offers a promising approach against antibacterial resistance, including fluoroquinolone-resistant strains. The study also emphasizes the importance of establishing an efficient extraction method to overcome the challenges associated with the low solubility of ZAB260, enabling precise quantification in complex cream formulations. Preliminary method development (mobile phase composition, pH of the mobile phase, selection of column) was carried out using S-Matrix Fusion Quality-by-Design software in conjunction with Agilent OpenLab ChemStation software. A C18 column with integrated phenyl functionality and a gradient mobile phase consisting of 10 mM potassium dihydrogen phosphate (pH 2.5) and acetonitrile was used for ultraviolet detection at 256 nm. The method was validated and demonstrated excellent linearity (correlation coefficient > 0.995), precision (RSD < 2%), and recovery (98–102%, RSD < 2%). The lack of a dedicated framework for the simultaneous estimation of parabens and poorly soluble NBTI in cream has prompted the need for a reliable analytical method. This study fills this gap by offering a comprehensive solution for simultaneous determination with accuracy, sensitivity, and robustness.