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A reverse phase UPLC method was developed for simultaneous determination of paracetamol, ibuprofen and its related impurity. The UPLC column was BEH C18 column, (2.1 × 100 mm, 1.7 μm). The mobile phase was composed of an aqueous solution of methanol-triethylamine in gradient mode. The UV detector wavelength was set at UV 230nm for paracetamol and ibuprofen for 254nm for the impurity. The calibration curves all showed good linear regression (r >0.999) within the concentration ranges of 50 – 600 μg/mL for paracetamol, 50-600 μg/mL for ibuprofen and 0.05-0.5 μg/mL for the impurity. The RSDs of precision were < 2% for paracetamol, ibuprofen and < 2.5% for the impurity. The LOD and LOQ of ibuprofen impurity were 0.03 μg/mL and 0.05 μg/mL, respectively. The recovery of these three compounds was in the range of 98-102%. The proposed RP -UPLC method showed simple, time-saving (<10 min. for a run), but quite precise and accurate, and as such, applicable to the routine assessment of paracetamol, ibuprofen and the impurity of ibuprofen in pharmaceutical dosage forms.

Rapid and simultaneous determination of paracetamol, ibuprofen and related impurity of ibuprofen by UPLC/DAD