Validation of method for RP-HPLC for the determination of Etoricoxib in coated tablets

Etoricoxib is a non-steroidal anti-inflammatory drug (NSAID) and selective inhibitor of the cyclooxygenase II (COX-II) enzyme. This drug is indicated in pathologies associated with the osteoarticular system with symptoms like pain and inflammation. Being selective for COX-II enzyme, it has greater efficiency in the treatment of pain, and it has less gastrolesive effects, among other unwanted effects associated with the chronic use of non-selective NSAIDs.

In the present work, an analytical method for the determination, by HPLC, of the content of Etoricoxib in coated tablets was validated. The validation of the proposed method was performed according to the parameters established in the USP 38, specifically in its section <1225>, corresponding to the validation of analytical methods.

The analytical method was developed under the following chromatographic conditions: Column C18 (3.0 mm X 150 mm, 3.5 μm), mobile phase constituted by a proportion of acetonitrile / water (35:65) at pH 7.0, mobile phase flow 0.7 mL / min and a wavelength of 236 nm.

The proposed method presented linearity in a concentration range from 0.07 mg / mL to 0.14 mg / mL. This analytical method produced exact, precise and robust results under the selected conditions and is unequivocally selective for the determination of Etoricoxib, being able to be an indicator of stability.