A Stability-Indicating Validated RP-HPLC Method for the Determination of Etoricoxib and It’s Degradants: Investigation of Greenness and Functionality of the Developed Method

Etoricoxib is a novel NSAID that belongs to selective COX-2 inhibitors. The aim of this research is to develop a precise, selective, cost-effective, and validated HPLC analytical method for the quantitative determination of Etoricoxib and its degradants. The analysis was implemented on a C18 column (150 × 4.6 mm, 5 μm particle size) using a mobile phase containing methanol and ammonium acetate (60:40) at a flow rate of 0.9 mL/min, with the Photodiode Array detector wavelength set at 234 nm. The method was validated according to USP43-NF38 guidelines and the International Conference on Harmonization recommendations. Linearity was established with a correlation coefficient value of 0.9999. The selectivity, accuracy, precision, and robustness of the method showed results within the acceptance criteria. Detection limit (DL) and quantification limit (QL) were 0.21 μg/ml and 0.72 μg/ml, respectively. Etoricoxib was subjected to several forced degradation factors, such as alkali and acid hydrolysis, heat degradation, photolytic degradation, and oxidative degradation. The degradants were successfully separated from the drug using the developed analytical method. Degradation of Etoricoxib was observed in oxidation, thermolysis, photolysis, and basic hydrolysis, while it was found stable in acid hydrolysis. Stress studies showed that maximum degradation of Etoricoxib was observed upon exposure to oxidation. Assessment of greenness was investigated using AGREE (Analytical greenness Metric approach). The Method approach’s functionality was evaluated using BAGI (Blue applicability Grade Index). Hence, the results indicated that the method can be used as an efficient tool for routine testing in QC laboratories and the pharmaceutical industry.