Separation of Etoricoxib and Its Degradation Products in Drug Substance Using UPLCTM

Abstract

A UPLCTM 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 UPLCTM BEH C18
column (1.7 Å, 2.1 x 100 mm) maintained at 25ÇC, 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 Åg.mL-1
. The method was
validated for precision, linearity, LOD and LOQ. Stability indicating capability was established by
forced degradation experiments.