Abstract

DEVELOPMENT AND VALIDATION OF A REVERSE PHASE HPLC METHOD FOR THE DETERMINATION OF ETORICOXIB IN PHARMACEUTICAL DOSAGE FORMS

Battula Sreenivasa Rao* and VDN Kumar Abbaraju

ABSTRACT

Etoricoxib {5-chloro-3-(4-methanesulfonylphenyl)-6’-methyl-[2,3] -bipyridinyl} (Fig. 1) is the newest addition to the group of nonsteroidal anti-inflammatory drugs. A rapid specific reverse-phase HPLC method has been developed for assaying Etoricoxib in pharmaceutical dosage forms. Both Etoricoxib and the internal standard were eluted under isocratic mode using a 150 X 4.6 mm i.d, 5μm Phenomenex ODS 2 C18 column. The mobile phase composed a mixture of 75:25 % v/v Methanol and 10mM Potassium Di hydrogen Phosphate (pH adjusted to 3.2) at a flow rate of 0.8 mL/minute. The wavelength of detection is 287 nm. The injection volume is 20 μL. The runtime of the method is 8 minutes. The method showed good linearity in the range of 4.99 – 99.70 μg/mL. The recovery of Etoricoxib is calculated at 3 levels Low, Medium & High and the recovery values are 99.80 %, 100.72 % & 102.20 % respectively. The LOD of Etoricoxib is 0.10μg/mL & LOQ is 0.25μg/mL. The retention time of Etoricoxib is 3.2 ± 0.2 minutes and that of Internal standard is 6.6 ± 0.2 minutes. The method is validated and is confirmed to have ruggedness & robustness. Stress degradation studies were done in Acid, alkaline, photolytic & oxidative environment and compared with freshly prepared samples. The proposed method has been successfully used for the estimation in tablet dosage forms.

Keywords: Etoricoxib; COX-2; Anti-inflammatory; HPLC, Pharmaceutical formulations.