RP-HPLC METHOD FOR DETERMINATION OF TOLPERISONE HYDROCHLORIDE IN TABLET FORMULATION

The study describes a validated stability indicating reverse-phase HPLC method for the estimation of tolperisone in bulk and in tablet formulation. The proposed RP-HPLC method utilizes a Hypersil C18 column (250 × 4.6 mm, 5 μm), optimum mobile phase consisted of methanol: acetonitrile: water (containing triethylamine 1% V/V) in the ratio of (85:10:5 V/V/V), effluent flow rate was kept at 1.0 mL/min and UV detection wavelength 250 nm. Tolperisone was exposed to various hydrolytic, thermal, photolytic and oxidative stress conditions, and the stressed samples were analysed by proposed method. The drug showed degradation under alkali and neutral hydrolysis and oxidative stress conditions. The degradation products were well resolved from the drug and demonstrated that the method is specific stability indicating for assay of tolperisone in presence of degradation products. The developed method was validated for linearity, accuracy, precision, robustness, ruggedness and specificity.