Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TOLPERISONE AND PARACETAMOL BY RP-HPLC

N. Anjaneyulu*, R. Naga Kishore, A. Teja Sri, B. Niharika, M. Vyshnavi1 and C. Chaithanya

ABSTRACT

A simple, sensitive, accurate, precise and rapid reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Tolperisone and Paracetamol from synthetic mixture. The chromatographic separation was performed on Imo Sil 5 C18 column (250 mm × 4.6 mm i.d, 5 μm particle size). Mobile phase consisted of a Acetonitrile and methanol in the ratio of 25:75, v/v at a flow rate of 1.0 ml/min. The detection wavelength was set at 261nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the concentration range of 10-30 μg/ml for Tolperisone and 5-15 μg/ml for Paracetamol. The retention times were found to be 5.3 ± 0.14min for Paracetamol and 2.4 ± 0.13min for Tolperisone. The mean recoveries were 100.5 ± 0.34 and 98.2 ±0.80 for Tolperisone and Paracetamol, respectively. The method can be easily adopted for quality control analysis.

Keywords: Tolperisone, Paracetamol, HPLC, Validation.