Stability Indicating RP-HPLC-PDA Method for Simultaneous Determinationof Dexketoprofen Trometamol and Paracetamol from tablet dosage form

摘要

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of Dexketoprofen trometamol and Paracetamol from tablet dosage form using a Hypersil BDS, C18 column (5μ, 4.5 mm x 250 mm) column and mobile phase composed of 0.01m Potassium Dihydrogen Phosphate: acetonitrile (75:25 v/v) pH 6.0 adjusted with Triethylamine, at flow rate of 1 ml/min. The retention time of Dexketoprofen Trometamol and Paracetamol were found to be 6.732 and 3.256 min respectively. Linearity was established for both drugs in the concentration range of 50-150 μg/ml. The percentage recoveries of Dexketoprofen Trometamol and Paracetamol were found to be in the range of 98.12%-101.82% and 98.15%-101.8% respectively. Detection was carried out at wavelength 254nm using photodiode array detector. The separation was carried out at 400 C temperature. Both the drugs were subjected to acid, alkali, neutral hydrolysis, oxidation, dry heat, and UV degradation. The degradation studies indicated Dexketoprofen trometamol and Paracetamol showed degradation in acid and alkali. The degradation products of Dexketoprofen trometamol and Paracetamol in acidic and alkali were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of Dexketoprofen trometamol and Paracetamol in tablet formulations.