Tolperisone hydrochloride

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical derivative spectroscopic method for the simultaneous determination of tolperisone hydrochloride (TOL) and diclofenac sodium (DIC) in bulk and synthetic mixture. Derivative spectroscopy offers a useful approach for the analysis of drugs in mixtures. In this study a first-derivative spectroscopic method was used for simultaneous determination of tolperisone hydrochloride and diclofenac sodium using the zero-crossing technique. The measurements were carried out at wavelengths of 250.60 and 311.20nm for tolperisone hydrochloride and diclofenac sodium respectively. The method was found to be linear (r2>0.9970) in the range of 5- 40 μg/ml for tolperisone hydrochloride at 250.60 nm. The linear correlation was obtained (r2>0.9990) in the range of 5-50 μg/ml for diclofenac sodium at 311.20 nm. The limit of determination was 0.65 and 0.55 μg/ml for tolperisone hydrochloride and diclofenac sodium respectively. The limit of quantification was 2.01 and 1.67 μg/ml. The method was successfully applied for simultaneous determination of tolperisone hydrochloride and diclofenac sodium in binary mixture.

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of diclofenac sodium and tolperisone hydrochloride in bulk and synthetic mixture. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ-max of one of the two components. Tolperisone hydrochloride and diclofenac sodium show an isoabsorptive point at 267 nm in methanol. The second wavelength used is 255 nm, which is the λ-max of tolperisone hydrochloride in methanol. The linearity was obtained in the concentration range of 2-20 μg/ml for both tolperisone hydrochloride and diclofenac sodium. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of tolperisone hydrochloride. The method was successfully applied to pharmaceutical dosage form because no interference from the synthetic mixture excipients was found. The suitability of this method for the quantitative determination of tolperisone hydrochloride and diclofenac sodium was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of tolperisone hydrochloride and diclofenac sodium in synthetic mixture or pharmaceutical dosage form. The results of analysis have been validated statistically and by recovery studies.