Journal of Advanced Drug Delivery (JADD) Estimation of Tolperisone Hydrochloride in Tablet Dosage Form by RP-HPLC Method

S Mahaparale, I Gonjari
A simple, rapid, selective, sensitive, accurate and precise High Performance Liquid Chromatography (HPLC) with UV detection method has been developed and validated for determination of Tolperisone hydrochloride in tablet dosage form. Tolperisone hydrochloride is a piperidine derivative, is a centrally-acting muscle relaxant. Chemically it is 2-methyl-1-(4-methylphenyl)-3-(1-piperidyl) propan-1-one. The chromatographic separation of Tolperisone hydrochloride was achieved using 250 x 4.6 mm, i.d.
more » ... 250 x 4.6 mm, i.d. 5 μm Chromasil C-18 column using a mobile phase acetonitrile: water pH adjusted to 3.0 with O-Phosphoric acid (60:40 v/v) at flow rate 1.0 ml/min. and the wavelength for detection at 260.0 nm using UV detector. The linearity for Tolperisone hydrochloride was found to be 5-60 μg/ml with regression coefficient (r 2) 0.9992. The retention time for Tolperisone hydrochloride was found to be 4.072 min. The percent recoveries for Tolperisone hydrochloride was obtained at 99.70. The relative standard deviation for intraday and interday precision in tablet was always less than 2%. The method was validated for linearity, range, precision, accuracy, specificity, selectivity, intermediate precision, ruggedness, robustness, stability and suitability.