Quantitative Determination of Etoricoxib and Paracetamol in Pharmaceutical Dosage Form and in-vitro comparison by Reversed-Phase High Performance Liquid Chromatography (RP-HPLC)

The objective of this present work was to develop and validate analytical method for quantitative determination of Paracetamol and Etoricoxib in a tablet formulation and also the comparison of invitro data with reference dosage form. Chromatographic separations of the two drugs were analyzed on a Kromasil C18 column (25cm X 4.6mm, 5 m). The mobile phase constituted of Buffer: Acetonitirile with gradient program was delivered at the flow rate 1.0 mL/min. Detection was performed at 220 nm. Separation was completed within 20 min. Calibration curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 48 to 146 g/mL of Paracetamol and 6 to 19 g/mL for Etoricoxib respectively. The relative standard deviation (R.S.D) was found to be less than 2.0%. Analysis for dissolution study was also performed by Reversed-Phase High Performance Liquid Chromatography (RP-HPLC) method. Difference factor (f1) were found to be 2.85 and 3.83 and similarity factor (f2) were found to be 73.514 and 68.961 for Paracetamol and Etoricoxib respectively.