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A simple, novel, sensitive, and specific spectrophotometric method was developed and validated for the determination of Tolperisone in bulk and its dosage forms. The proposed method was based on the interaction of the drug with 2,4-dinitrophenylhydrazine in the presence of an acid catalyst, followed by treatment with a methanolic solution of potassium hydroxide; an intensely colored chromogen was formed that was measured in dimethyl formamide as the diluting solvent at 520 nm. All variables affecting the development of the measured chromogen were studied and optimized. Beer's law was obeyed in the concentration ranges of 2.5-15 µg/ml with good correlation coefficient of 0.9995. The limit of detection (LOD) and limit of Quantification (LOQ) for this method are 0.344 and 1.043 µg/ml respectively, and the relative standard deviation of intra-day precision was 1.10% and inter-day precision was 1.42%. The proposed method was applied successfully for the determination of Tolperisone in pure bulk form and in tablets without interference from commonly encountered additives.
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