Rapid Approach for Pharmaceutical Quality Evaluation and Comparison

摘要

A rapid approach, with the association of Fourier-transform infrared spectroscopy (FTIR) and nuclear magnetic resonance spectroscopy (NMR), is proposed in order to provide a fast quality evaluation of pharmaceutical products. It offers an analytical screening tool also useful to compare drug products including generics. The approach requires a minimal amount of solvents and little sample preparation. In this paper characterization of pharmaceutical product samples containing telmisartan, allopurinol, anastrozole, metformin hydrochloride and lamivudine, active pharmaceutical ingredients (APIs) in solid dosage forms, are reported. The results show how this approach can provide useful data for a rapid screening of pharmaceutical composition and comparison of drugs with useful information also in terms of equivalence risk analysis.