Development and Validation of Ratio Spectra Derivative Spectrophotometric Method for Simultanious Analysis of Tolperisone Hydrochloride and Paracetamol in Synthetic Mixture

The Ratio spectra derivative spectrophotometric method was developed for the simultaneous determination of Tolperisone(TOL) and Paracetamol (PCM) in combined dosage forms. The method depends on the use of the first derivative of theratio-spectra obtained by dividing the absorption spectrum of binary mixtures by a standard spectrum of one of the compounds. The first derivative amplitudes at 261.2 and 221 nm were selected for the determination of TOL and PCM respectively. The wavelength interval (Dl) was selected as 8 nm. Distilled water was used as the solvent. Both the drugs showed linearity in the range of 2-14 ?g/ml. The method was validated statistically and recovery studies were carried out. It was found to be accurate, precise and reproducible. The method was applied to the assay of the drugs in synthetic formulation, which were found in the range of 99.77% and 100.3% of the labeled value for both Tolperisone and Paracetamol. Hence, the method here in described can be successfully applied in quality control of combined pharmaceutical dosage forms