DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE ESTIMATION OF TOLPERISONE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

A rapid, specific and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method was developed for the determination of Tolperisone Hydrochloride (TOLP) in bulk and tablet dosage form. The method involved an isocratic elution of TOLP on C 18 column (250 X 4.6 mm, 5 µm) using a mobile phase composition of acetonitrile: 20 mM ammonium acetate buffer containing 0.1% triethyl amine (55:45 v/v) (pH 4.0 adjusted by glacial acetic acid), at a 1.0 ml/min flow rate. The analyte was monitored at 260 nm wavelength. The retention time for tolperisone was found to be 2.50 min. Linearity was established in range of 12.5 - 100 µg/ml with correlation coefficient 0.999. The % recovery was obtained as 98.38 – 101.58 %. The detection limit and quantitation limit were found to be 0.172 and 0.521 respectively. This method can be successfully employed for quantitative analysis of TOLP in bulk and pharmaceutical dosage form as its accuracy, precision, specificity and reproducibility.