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Abstract

The study describes a validated reverse-phase HPLC method for the simultaneous estimation of paracetamol and naproxen in bulk and in tablet formulation. The proposed RP-HPLC method utilizes Eclipse XDB C18 column (150 ×4.6 mm i.d., 5 µm), optimum mobile phase consisted of gradient run of initial ratio of water (pH-2.5 adjusted with orthophosphoric acid): acetonitrile (87:13) with the effluent flow rate of 1.0 ml/min, and UV detection wavelength 263 nm. The developed method was statistically validated for linearity, precision, robustness, ruggedness and specificity. The method was linear over the range of 5-80 µg/ml for paracetamol and 3-48µg/ml for naproxen. The mean recovery was 99.72% and 100.88% for paracetamol and naproxen respectively. The intermediate precision data obtained under different experimental setup was quite concurrent with less critical % RSD. The proposed method can be useful in the quality control of paracetamol and naproxen in bulk drug and drug products.