Novel Stability Indicating RP-UPLC Method Development and Validation for The Quantification of Nefopam Hydrochloride in Tablet Dosage Form and Characterization of Its Degradation Products

A novel stability indicating RP-UPLC method has been developed for the estimation of Nefopam hydrochloride in bulk and pharmaceutical dosage form. The Chromatographic separation was achieved on C18 (4.6 mm * 100 mm; 3 microns) column using the mobile phase buffer: acetonitrile: methanol in the ratio of 50:41:9 at a flow rate of 0.6 ml/min. The detection wavelength was 225 nm. Linearity was obeyed in the concentration of 22.63 µg/ml to 67.90 µg/ml. The recovery of Nefopam was found to be 99.72 %. In precision study % RSD was found to be 0.47 for repeatability and 0.60 % for intermediate precision. By using the developed method, percentage label claim of marketed formulation was found to be 100.39%. Forced degradation studies showed significant degradation under Acid hydrolysis. This UPLC method is suitable for routine quality control of Nefopam hydrochloride in pharmaceutical formulation, effectively distinguishing degradation products and ensuring regulatory compliance.