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

A rapid, accurate, and precise UPLC method was developed for the simultaneous estimation of Haloperidol (HPD) and Benzhexol (BZH) in bulk and combined dosage forms. Chromatographic separation was achieved on a BDS C18 column (250 × 4.6 mm, 5 µm) using a mobile phase of acetonitrile and 0.1% orthophosphoric acid (55:45, v/v) at a flow rate of 1 mL/min, with detection at 210 nm. The method was validated as per ICH guidelines, exhibiting excellent linearity, accuracy, precision, and robustness. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed the method’s stability-indicating capability, with no interference observed from degradation products. The developed method is simple, reliable, and well-suited for routine quality control and stability assessment of Haloperidol and Benzhexol in pharmaceutical formulations.