Rapid Approach for Pharmaceutical Quality Evaluation and Comparison. Issue 20 (23rd May 2022)

• Record Type: Journal Article
• Authors: Pettinau, Francesca; Manca, Ilaria; Manca, Ilaria; Pittau, Barbara
• Is Part Of: ChemistrySelect. Volume 7:Issue 20(2022)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2022-05-23
• Subjects: Branded -- Equivalence -- Generic -- IR spectroscopy -- NMR spectroscopy -- Pharmaceutical products -- Quality comparison -- Quality evaluation; Chemistry -- Periodicals; 540.5
• DOI: 10.1002/slct.202200712
• Languages: English
• ISSNs: 2365-6549

Abstract

Abstract: 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. Abstract : Rapid approach by a combination of Fourier‐transform infrared spectroscopy (FTIR) and nuclear magnetic resonance spectroscopy (NMR) to provide a fast quality evaluation of pharmaceutical products. The aim is to offer an analytical tool for a rapid screening of pharmaceutical composition and comparison of drugs with useful information also in terms of equivalence risk analysis.