A simple, precise, and accurate method was developed for the estimation of Tolperisone (TOL) and Paracetamol (PCM) in synthetic mixture using second order derivative spectrophotometry. Wavelengths selected for quantitation were 257.3 nm for Tolperisone (zero crossing point of Paracetamol) and 218.8 nm for Paracetamol (zero crossing point of Tolperisone). The method was validated with respect to linearity, accuracy, precision, limit of detection and limit of quantitation in accordance with the International Conference on Harmonisation (ICH) guidelines. Linearity was observed in concentration range of 2-14 �µg/ml for each Tolperisone and Paracetamol. The limit of detection and limit of quantitation were found to be 0.275 �µg/ ml and 0.883 �µg/ ml for Tolperisone and 0.126 �µg/ ml and 0.384 �µg/ ml for Paracetamol. The percentage recovery of Tolperisone and Paracetamol was found to be 99.53% and 99.39%, respectively. The % R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was precise. The method can be successfully employed for the simultaneous estimation of Tolperisone and Paracetamol in synthetic mixture.
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