title: Near-infrared spectroscopy (NIRS) and chemometric analysis of Malaysian and UK paracetamol tablets: a spectral database study.
abstract: The influx of medicines from different sources into healthcare systems of developing countries presents a challenge to monitor their origin and quality. The absence of a repository of reference samples or spectra prevents the analysis of tablets by direct comparison. A set of paracetamol tablets purchased in Malaysian pharmacies were compared to a similar set of sample purchased in the UK using near-infrared spectroscopy (NIRS). Additional samples of products containing ibuprofen or paracetamol in combination with other actives were added to the study as negative controls. NIR spectra of the samples were acquired and compared by using multivariate modeling and classification algorithms (PCA/SIMCA) and stored in a spectral database. All analysed paracetamol samples contained the purported active ingredient with only 1 out of 20 batches excluded from the 95% confidence interval, while the negative controls were clearly classified as outliers of the set. Although the substandard products were not detected in the purchased sample set, our results indicated variability in the quality of the Malaysian tablets. A database of spectra was created and search methods were evaluated for correct identification of tablets. The approach presented here can be further developed as a method for identifying substandard pharmaceutical products.
authors.affiliation: The School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX, UK.
authors.forename: Mazlina M
authors.initials: MM
authors.lastname: Said
authors.forename: Simon
authors.initials: S
authors.lastname: Gibbons
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Moffat
authors.forename: Mire
authors.initials: M
authors.lastname: Zloh
mesh_terms: D000082:Acetaminophen / Q000032:analysis / Q000737:chemistry*; D000465:Algorithms; D018712:Analgesics, Non-Narcotic / Q000032:analysis / Q000737:chemistry*; D058110:Counterfeit Drugs / Q000032:analysis / Q000737:chemistry*; D016208:Databases, Factual; D003906:Developing Countries; D004345:Drug Industry / Q000379:methods / Q000592:standards; D008296:Malaysia; D008956:Models, Chemical; D025341:Principal Component Analysis; D011786:Quality Control; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets; D006113:United Kingdom
chemical_list: D018712:Analgesics, Non-Narcotic; D058110:Counterfeit Drugs; D013607:Tablets; D000082:Acetaminophen