A rapid, specific, and sensitive reverse phase high performance liquid chromatographic method has been developed and validated for analysis of tolperisone in both bulk and pharmaceutical dosage form. The HPLC method was performed with a reversed phase C18 SunFire column (250？mm × 4.6？mm i.d., 5？mm particle size), detection at 261？nm and a mixture of methanol, water and pH 7.5 adjusted by use of 1% solution of triethylamine (60？:？40) as mobile phase. The flow rate was 1.0？mL？min？1 and effluents were monitored at 261？nm. The retention time of tolperisone was 4.8 min. Tolperisone was subjected to acid and alkali hydrolysis, chemical oxidation, wet hydrolysis, dry heat degradation, and sunlight degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision, and robustness. The method was successfully applied to the estimation of tolperisone in tablet dosage forms. 1. Introduction Tolperisone (TOL) a central muscle relaxant suitable for cerebral arteriosclerosis and for treating extrapyramidal movement disorders [1] is 2-methyl-1-(4-methylphenyl)-3-(1-piperidyl) propan-1-one, a piperidine derivative. Tolperisone has the unique property of mediating muscle relaxation without concomitant sedation and it does not cause coordination, weakness, and mental confusion or withdrawal phenomena, in contrast to other muscle relaxants. Its molecular formula and molecular weight are · and 281.83, respectively. Tolperisone HCl is extremely water soluble; it is more stable in acidic medium [2–4]. Comprehensive literature survey reveals that several analytical methods have been reported for the estimation of tolperisone which includes potentiometry [5], spectroscopy [6–8], high performance thin layer chromatography (HPTLC) [9], and high performance liquid chromatography [10, 11]. The reported RP-HPLC methods are aimed at quantifying tolperisone in biological fluids [12, 13]. Literature review revealed that stability indicating RP-HPLC method [14] has been reported for the estimation of tolperisone in pharmaceutical dosage form. In the proposed study, attempt has been made to develop sensitive stability indicating RP-LC method for the estimation of TOL in bulk and pharmaceutical dosage form [15]. 2. Materials and Methods 2.1. Instrumentation 2.1.1. High Performance Liquid Chromatography The liquid chromatographic system of waters (Calcutta, India) containing
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