DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METAXALONE AND DICLOFENAC POTASSIUM IN TABLET DOSAGE FORM

The study describes method development and subsequent validation of RP-HPLC method for simultaneous estimation of metaxalone and diclofenac potassium in combined tablet dosage forms. Chromatographic separation was achieved on an Inertsil ODS 3V (250 mm × 4.6 mm id, 5μm) column using a mobile phase consisting of (30:30:40v/v/v) water: methanol: acetonitrile at a flow rate of1.2ml/min. The detection wavelength is 218 nm. The retention times of metaxalone and diclofenac potassium were found to be 2.610 min and 4.607 min respectively. The developed method was validated as per ICH guidelines .The developed and validated method was successfully used for the quantitative analysis of metaxalone and diclofenac potassium in tablet dosage forms.