Analytical Method Development and Validation of Related Substances in Etoricoxib (API) by Using RP-HPLC

Abstract

This article describes the development and validation of related substances in Etoricoxib by using RP-HPLC and degradation products generated from the forced degradation studies. Etoricoxib was subjected to stress conditions such as acid, alkaline, oxidative, thermal and photo degradation. It was found to be stable in all these conditions except in oxidation environment. Successful separation of drugs was achieved on Inertsil ODS-3V, (4.6x250 mm, 5 μm) C18 at 25 oC. Gradient elution at a flow rate of 1.0 mL/min. The mobile phase consisted of mixture of Buffer: Acetonitrile Buffer (0.01 M KH2PO4) in the ratio of 90:10 (v/v) respectively and UV detection wavelength was 238 nm. The Rt value of Impurity-05A, Impurity-04 and Etoricoxib was found to be 3.09 min, 17.01 min and 21.45 min respectively with a run time of 45 min. Keyword: RP-HPLC, Etoricoxib, Method validation Introduction In this present study an attempt was made to develop RP-HPLC method and method validation of related substances in Etoricoxib in dosage form. The Etoricoxib (Figure 1) active ingredient is arcoxia 1,2 , etoricoxib is selective COX-2 inhibitor it inhibits the second isoform of cyclooxygenases enzyme (COX-2). Since COX-2 is crucial 3 in the production of prostaglandins, inhibition of COX-2 effectively decreases pain. Etoricoxib is indicated for the treatment of rheumatoid arthritis, Psoriatic arthritis, Osteoarthritis, ankylosing spondylitis, acute pain and gout. Its chemical formula is C18H15ClN2O2S and molecular weight 4 is 358.842 g/mol.