RP ? HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF METHYL PHENIDETE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS.

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Methyl phenidete hydrochloride in tablet dosage form. Isocratic elution at a flow rate of 1ml min-1 was employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of Methanol:acetonitrile:THF 75:20:05 (v/v/v). The UV detection wavelength was at 278nm.Linearity was observed in concentration range of 20-55ppm. The retention time for Methyl phenidete hydrochloride was 3.32 min. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Methyl phenidete hydrochloride in pharmaceutical dosage forms.