Earth-friendly-assessed chromatographic platforms for rapid analysis of sulfacetamide sodium and prednisolone acetate in presence of sulfanilamide impurity: Application on ophthalmic formulation and aqueous humor

Abstract

Sulfacetamide sodium as an antibacterial agent is co-formulated with prednisolone acetate in Phenamide-P® ophthalmic suspension to cure the ophthalmic infections correlated with inflammatory disorders. For the first time, two innovative, sensitive, specific, and robust chromatographic platforms were developed and their conditions were optimized for rapid analysis of the aforementioned drugs either in the absence or presence of sulfanilamide; a major impurity and degradation product of sulfacetamide sodium. The first platform is HPLC/UV in which separation of the three analytes was performed on a kinetex C18 column (4.6 × 100 mm, 2.6-μm) with isocratic elution using methanol: deionized water pH 3 (adjusted with orthophosphoric acid) in a ratio of (40:60 by volume) as a green mobile phase. The flow rate of the mobile phase was 1 mL/min and the UV detector was set at 262 nm. The second platform is HPTLC/densitometry in which the three analytes were separated on silica gel 60-F254 TLC plates using a developing system of chloroform: acetone: ammonia (6:2:0.1 by volume) and their developed bands were detected at 262 nm. The detection and quantitation limits were found in ranges of (0.01–0.03 μg/mL) and (0.03–0.09 μg/mL) for the HPLC platform while were found in ranges of (0.007–0.01 μg/band) and (0.02–0.04 μg/band) for the HPTLC platform, respectively. The suggested platforms were applied for the determination of sulfacetamide sodium and prednisolone acetate in spiked rabbit aqueous humor without interference by the matrix of aqueous humor. Greenness assessment was performed using eco-scale and GAPI tools revealing the excellent greenness of suggested platforms. According to ICH recommendations, the suggested platforms were validated producing satisfactory results within the accepted limits. The suggested platforms can be successfully applied for routine analysis of the aforementioned drugs not only in QC laboratories but also in the bioavailability centers due to the short analysis time of these platforms.