Development and Validation of Reverse phase high performance liquid chromatography method for simultaneous estimation of Paracetamol and Nabumetone in tablet dosage form

In this study, reverse phase high performance liquid chromatographic method have been developed and validated for the simultaneous determination of Paracetamol and Nabumetone in combined pharmaceutical formulation. HPLC separation was achieved with a Phenomenex – Luna, C18 (250 x 4.6 mm i.d., 5μ) as stationary phase and Methanol:Acetonitrile:Water (55:30:15 v/v/v) as eluent, at a flow rate of 0.6 ml/min. UV detection was performed at 239 nm. The retention time of Paracetamol and Nabumetone was found to be 4.2 and 7.2min respectively. Results of the analysis were validated statistically and by recovery studies. Linearity, accuracy, and precision were acceptable in the ranges of Paracetamol and Nabumetone (5-25 μg/ml) respectively. The calibration curves were linear (r2 > 0.999) in the range for each analyte. The % recovery for Paracetamol and Nabumetone is 100.49 and 99.42 respectively. No spectral or chromatographic interferences from the tablet excipients were found. The result of the studies showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which can be used for the routine determination of Paracetamol and Nabumetone in bulk and in its pharmaceutical dosage forms.

Author(s): K. Anand Babu and B. Jaykar

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