A simple, rapid reverse phase high performance liquid chromatographic method has been developed and validated for estimation of Tolperisone hydrochloride and paracetamol in pharmaceutical tablet dosage form. The estimation was carried out on Phenomenex C-18 column at 60 ºC having 250 x 4.6mm, 5µ size with a mixture of methanol: acetonitrile in the ratio of 65:35 :( v/v) as mobile phase. UV detection was performed at 254 nm. The method was validated for linearity, accuracy, precision and specificity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 2.6 min. for Paracetamol and 4.2 min. for Tolperisone hydrochloride. Total run time was 10 min. at a flow rate of 1.0 ml/min. The calibration curve was linear over the concentration range of 50-150 µg/ml for paracetamol and 25-125 µg/ml for tolperisone. The LOD and LOQ values were found to be 0.48 and 1.46 µg/ml for paracetamol and 0.93and 2.84 µg/ml for tolperisone. The high percentage of recovery confirms the suitability of the method for the estimation of Tolperisone in pharmaceutical dosage form.
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