Stability-Indicating HPTLC method for the determination of febuxostat in bulk and pharmaceutical formulation

Manisha P Puranik, Harsha S Bhoyar, Debarshi Kar Mahapatra

Department of Quality Assurance, Institute of Pharmaceutical Education and Research, Borgaon (Meghe), Wardha, Maharashtra, India

ABSTRACT

Febuxostat (FEB) is a well-known xanthine oxidase (XO) inhibitor that is preferably employed for treating hyperuricemia (extreme stages of uric acid in the human serum). In all the above, particularly, the high-performance thin-layer chromatography (HPTLC) method where the retention factor (Rf) values were found to be quite varying as well as no specific degradation have been yet studied under moisture, sunlight, oxidative stress, acidic environment, and alkaline conditions. The present study exclusively focuses on a much optimized stability-indicating HPTLC-based precise, accurate, and specific HPTLC method for FEB detection in the existence of its degradation components using densitometric detection. The study hereby opened a new perspective in developing a novel HPTLC method for the chromatographic determination of United States Food and Drug Administration (USFDA)-approved drug FEB in bulk and tablet formulations. The method was properly authenticated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2A and guideline Q2B and therefore is found to be accurate, linear, reproducible, precise, robust and economically adequate to execute day after day custom analysis in the pharmaceutical industry scale. The investigation also unties new opportunities for the coherent optimization of HPTLC-based validated analytical methods for other drug products alone as well as simultaneously for frequently available formulations.

Keywords:

Febuxostat, HPTLC, Tablet, Estimation, Stability-indicating, Validation