Raman Spectroscopy for the Quantitative Analysis of Solid Dosage Forms of the Active Pharmaceutical Ingredient of Febuxostat.

Raman spectroscopy has been used to characterize and quantify the solid dosage forms of the commercially available drug febuxostat. For this purpose, different formulations consisting of the febuxostat (API) and excipients with different concentrations of the API are prepared and analyzed by Raman spectroscopy to identify different spectral features related to the febuxostat API and excipients. Multivariate data analysis tools such as principal component analysis (PCA) and partial least-squares regression (PLSR) analysis are used for qualitative and quantitative analyses. PCA has been found to be useful for the qualitative monitoring of various solid dosage forms. PLSR analysis has led to the successful prediction of API concentration in the unknown samples with a sensitivity and a selectivity of 98 and 99%, respectively. Moreover, the root-mean-square error (RMSE) of calibration and validation of the PLSR model has been found to be 2.9033 and 1.35, respectively. Notably, it is found to be very helpful for the comparison between the self-made formulations of febuxostat and commercially available febuxostat tablets (40 and 80 mg) of two different brands (Gouric and Zurig). These results showed that Raman spectroscopy can be a useful and reliable technique for identifying and quantifying the active pharmaceutical ingredient (API) in commercially available solid dosage forms.