Original Articles: 2015 Vol: 7 Issue: 4
Development and validation of a stability indicating RP-UPLC method for the determination of paracetamol and ibuprofen in tablet
Abstract
The proposed work describes the development and validation of a simple, precise and accurate method for the combination tablet formulation of Paracetamol and Ibuprofen by UPLC. Efficient separations of the Paracetamol and Ibuprofen were achieved in < 3 min by an isocratic elution with 20mM potassium dihydrogen phosphate buffer (pH 7.35 with dilute ortho phosphoric acid): acetonitrile (35:65 v/v) mobile phase at a flow rate of 0.25ml/min at 225 nm using a PDA detector. In UPLC, all of the analytes were resolved very well the resolution between Paracetamol and Ibuprofen was 5.4. The method was developed using different columns like UPLC @ BEH C8, C18; phenyl and HSS T3 with different length of the columns had studied under RP conditions. The final column chosen for the analysis was HSS T3 (100mm ×2.1, 1.8 μm) column which provided much stronger retention and resolution with good peak shape. The retention time of Paracetamol and Ibuprofen were 1.09 and 1.88 min, respectively. The linearity was obtained in the concentration range of 6.66-59.94 μg/ml and 8.0-72.0 μg/ml for Paracetamol and Ibuprofen with 0.9999 of correlation coefficients respectively. The specificity of the method was analyzed by the stress degradation study in acidic, alkaline, oxidative, thermal and photolytic conditions. The LOD for Paracetamol and Ibuprofen was found 0.84 and 0.52 μg/ml respectively. The LOQ was found 2.81 and 1.73 μg/ml for Paracetamol and Ibuprofen respectively. The validation follows the International Conference on Harmonization (ICH) guidelines.