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 prese nt 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 μm). 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. Calibr ation curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 48 to 146 μg/mL of Paracetamol and 6 to 19 μg/mL for Etoricoxib respectively. The relative standard deviation (R.S.D) was found to be less than 2.0%. An alysis for dissolution study was also performed by Reversed - Phase High Performance Liquid Chromatography (RP - HPLC) method. Difference factor (f ₁) were found to be 2.85 and 3.83 and similarity factor (f₂) were found to be 73.514 and 68.961 for Paracetamol a nd Etoricoxib respectively.