RP HPLC method for the determination of Etoricoxib in bulk andpharmaceutical formulations

A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of etoricoxib in bulk and tablet dosage forms. It was found that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on Shimadzu HPLC, 10-At detector with hypersil ODS C18 Column 250 X 4.6 mm (particle size of 5μ) and constant flow pump. Rheodyne injector with 20 μl loop with a mobile phase composed in the ratio acetonitrile: (0.05M) KH2PO4 buffer (50:50) at flow rate 1.8 ml /min. The detection was monitored at 283nm. The calibration curve for etoricoxib was linear from 0.5-85mg/ml and internal standard (Bromhexine) 10mg/ml were prepared by suitable dilutions of the stock solution with appropriate mobile phase. The interday and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of etoricoxib in bulk and its tablet dosage forms. LOD and LOQ for etoricoxib were found to be 0.193 and 0.450.Accuracy (recoveries: 99.8-100.4%) and reproducibility were found to satisfactory.