Separation of Etoricoxib and Its Degradation Products in Drug Substance Using UPLC (TM)

A UPLC (TM) method was developed and validated for the separation of Etoricoxib and its degradation products in drug substance. The main drug and its seven major and few minor degradation products were well separated within seven minutes on acquity UPLC (TM) BEH C18 column (1.7 mu, 2.1 x 100 mm) maintained at 25 degrees C, using 0.01M acetate buffer pH 5.0 - acetonitrile (60 : 40, v/v) as mobile phase. The flow rate was 0.3 mL.min(-1) and observed backpressure was about 10500 psi. Detection was performed at 235 nm using PDA detector. Linearity was obtained in the concentration range of 0.05 - 120 mu g.mL(-1). The method was validated for precision, linearity, LOD and LOQ. Stability indicating capability was established by forced degradation experiments.