RP-HPLC Method Development and Validation of Rofecoxib in Bulk and Dosage Form

A rapid and precise RP-HPLC method has been developed for the validated of Rofecoxib, in its pure form as well as in tablet dosage form.Chromatography was carried out on a Symmetry C18 (4.6 x 150 mm, 5 µm) column using a mixture of Methanol and water (45:55 % v/v) as the mobile phase at a flow rate of 0.8 ml/min, the detection was carried out at 260 nm.The retention time of the Rofecoxib was 2.379 ±0.02 min respectively.The method produces linear responses in the concentration range of 24-120 mg/ml of Rofecoxib.The method precision for the determination of assay was below 2.0%RSD.The method is useful in the quality control of bulk and pharmaceutical formulations.