Analytical method development and validation for the simultaneous estimation of Paracetamol and Tapentadol by RP-HPLC in bulk and pharmaceutical dosage forms

A simple rapid, accurate, precise and reproducible validated reverse phase HPLC method was developed for the determination of Paracetamol and Tapentadol in bulk and pharmaceutical dosage forms. The quantification was carried out using Thermo hypersil BDS C18 (100 X 4.6 mm, 5 µm) column run in isocratic way using mobile phase comprising of Ammonium acetate buffer and methanol in the ratio of 50:50 w/v by adjusting the pH to 6.5(±0.5) with orthophosphoric acid and a detection wavelength of 280nm, and injection volume of 10µL, with a flow rate of 1.0ml/min. The retention times of Paracetamol and Tapentadol was found to be 1.362 and 2.273. The linearity ranges of the proposed method lies between 0.50 mg/mL to 0.150 mg/mL, which is equivalent to 50% to 150% and with correlation coefficient of r 2 =1.0 and 0.999 for Paracetamol and Tapentadol . The assay of the proposed method was found to be 101.0% and 98.0%. The recovery studies were also carried out and mean % Recovery was and found to be 99.0% to 99.0%. LOD values for Paracetamol and Tapentadol was found to be 0.22 and 0.64 respectively and LOQ were found to be 0.68 and 1.96 respectively. The % RSD from reproducibility was found to be <2%. The proposed method was statistically evaluated and can be applied for routine quality control analysis of Paracetamol and Tapentadol in bulk and in Pharmaceutical dosage form.