Vol. 7, Issue 2, Part D (2025)

Chromatographic separation of Bromhexine and Sulbactam was achieved using an Altima C18 column with a mobile phase of phosphate buffer (pH 4.0) and acetonitrile (40:60, v/v) at a flow rate of 1.0 mL/min. The retention times were 2.1 min for Bromhexine and 3.2 min for Sulbactam. Method validation, conducted according to ICH guidelines, demonstrated excellent linearity (r² = 0.999), high accuracy (99.9-100.1%), and precision with %RSD below 2. Sensitivity was confirmed with LODs of 0.04-0.09 µg/mL and LOQs of 0.11-0.27 µg/mL. Robustness testing indicated reliable performance under minor analytical variations. Forced degradation studies confirmed the method’s stability-indicating capability, showing significant degradation under alkaline and oxidative conditions, while thermal, acidic, and UV stresses caused minimal changes. This rapid and sensitive UPLC method is suitable for routine quality control and stability analysis of Bromhexine and Sulbactam in pharmaceutical formulations.