Exciting Advances in Sustainable Spectrophotometric Micro-Quantitation of an Innovative Painkiller “Tramadol and Celecoxib” Mixture in the Presence of Toxic Impurity, Promoting Greenness and Whiteness Studies

Abstract

Background Tramadol (TRM) and celecoxib (CLX) are a novel mixture that helps relieve impetuous, acute pain when other painkillers have no action. It is also reported that the currently studied drugs, tramadol and celecoxib, are used to control COVID-19 symptoms. Objective The current work highlights three important pillars of modern pharmaceutical analysis, which are as follows; impurity profiling, greenness/whiteness studies and simplicity accompanied by sensitivity. Since 4-methyl acetophenone inhibits the human carbonyl reductase enzyme (type I), and since this compound may pose a health risk, it is crucial to regulate its concentration in all dosage forms of CLX. Methods Two simple and green spectrophotometric methods were developed, namely; Third Derivative (D3) and Fourier Self Deconvulation (FSD) for resolving severely overlapped spectra of tramadol and celecoxib in the presence of 4-methyl acetophenone (4-MAP) as a process-related impurity in their novel tablet combination. Results The two approaches showed acceptable linearity with an excellent correlation coefficient. Simply, for both methods tramadol was measured when celecoxib and 4-methyl acetophenone were zero-crossing. The same procedure was applied for measuring celecoxib and its process-related impurity; 4-methyl acetophenone. Conclusion The methodologies developed were thoroughly validated in compliance with ICH guidelines. Student t and F-tests revealed no statistically substantial variation among the current methods and the reported method. Highlights No spectrophotometric methods have been published for the simultaneous analysis of TRM and CLX along with 4-MAP. As a result, the newly developed spectrophotometric approaches hold great relevance and originality in the field of pharmaceutical analysis.