Volume-2 ,Issue-4, April-2026

The primary objective of this study was to develop and validate a simple, cost-effective, and reliable UV-spectrophotometric method for the simultaneous estimation of Paracetamol and Ofloxacin in a combined oral suspension dosage form. Pre-formulation studies, including organoleptic evaluation, solubility profiling, melting point determination, and FTIR spectroscopy, were conducted to ensure the purity and structural integrity of the active pharmaceutical ingredients (APIs). A dual-wavelength spectrophotometric method was developed using Methanol as the common solvent, while the suspension was formulated using Carbopol 934 as a suspending agent and evaluated for physical stability, pH, and rheological properties. Method validation was performed in strict accordance with ICH Q2(R1) guidelines, assessing linearity, precision, ruggedness, robustness, and sensitivity (LOD/LOQ). The maximum absorption lambda max was identified at 248.0 nm for Paracetamol and 297.5 nm for Ofloxacin, with a combined overlay peak at 274.5 nm. The method demonstrated excellent linearity R2 > 0.987 over the concentration ranges of 2-14 ug/mL and 5-30 ug/mL, respectively. Precision studies yielded %RSD values significantly below 2%, confirming high reproducibility across intraday and interday assessments. The formulated suspension exhibited a stable pH of 6.8 and an optimal viscosity of 3182\ cps, ensuring uniform drug distribution and ease of administration. In conclusion, the developed UV-spectrophotometric method is accurate, precise, and robust, offering a high-throughput alternative to expensive chromatographic techniques. Combined with the successful formulation of a stable oral suspension, this study provides a standardized approach for the routine quality control and delivery of Paracetamol and Ofloxacin in pediatric and adult therapeutics.

Keyword: Paracetamol, Ofloxacin, UV-Spectrophotometry, Method Validation, Oral Suspension, ICH Guidelines