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Title: Development of NIRS method for quality control of drug combination artesunate-azithromycin for the treatment of severe malaria
Authors: Chantal Boyer
Karen Gaudin
Tina Kauss
Alexandra Gaubert
Abdelhakim Boudis
Justine Verschelden
Mickaël Franc
Julie Roussille
Jacques Boucher
Piero Olliaro
Nicholas J. White
Pascal Millet
Jean Pierre Dubost
Developpements Analytiques et Pharmaceutiques Appliques aux Maladies Negligees et Aux Contrefacons
Organisation Mondiale de la Sante
Mahidol University
University of Oxford
Keywords: Biochemistry, Genetics and Molecular Biology;Chemistry;Medicine;Pharmacology, Toxicology and Pharmaceutics
Issue Date: 1-Aug-2012
Citation: Journal of Pharmaceutical and Biomedical Analysis. Vol.67-68, (2012), 10-15
Abstract: Near infrared spectroscopy (NIRS) methods were developed for the determination of analytical content of an antimalarial-antibiotic (artesunate and azithromycin) co-formulation in hard gelatin capsule (HGC). The NIRS consists of pre-processing treatment of spectra (raw spectra and first-derivation of two spectral zones), a unique principal component analysis model to ensure the specificity and then two partial least-squares regression models for the determination content of each active pharmaceutical ingredient. The NIRS methods were developed and validated with no reference method, since the manufacturing process of HGC is basically mixed excipients with active pharmaceutical ingredients. The accuracy profiles showed β-expectation tolerance limits within the acceptance limits (±5%). The analytical control approach performed by reversed phase (HPLC) required two different methods involving two different preparation and chromatographic methods. NIRS offers advantages in terms of lower costs of equipment and procedures, time saving, environmentally friendly. © 2012 Elsevier B.V.
ISSN: 1873264X
Appears in Collections:Scopus 2011-2015

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