title: Development of NIRS method for quality control of drug combination artesunate-azithromycin for the treatment of severe malaria.
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.
authors.affiliation: Développements Analytiques et Pharmaceutiques appliqués aux Maladies Négligées et aux Contrefaçons, EA 4575, Université Bordeaux Segalen, 146 Rue Léo Saignat, 33076 Bordeaux Cedex, France.
authors.forename: Chantal
authors.initials: C
authors.lastname: Boyer
authors.forename: Karen
authors.initials: K
authors.lastname: Gaudin
authors.forename: Tina
authors.initials: T
authors.lastname: Kauss
authors.forename: Alexandra
authors.initials: A
authors.lastname: Gaubert
authors.forename: Abdelhakim
authors.initials: A
authors.lastname: Boudis
authors.forename: Justine
authors.initials: J
authors.lastname: Verschelden
authors.forename: Mickaël
authors.initials: M
authors.lastname: Franc
authors.forename: Julie
authors.initials: J
authors.lastname: Roussille
authors.forename: Jacques
authors.initials: J
authors.lastname: Boucher
authors.forename: Piero
authors.initials: P
authors.lastname: Olliaro
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: White
authors.forename: Pascal
authors.initials: P
authors.lastname: Millet
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Dubost
mesh_terms: D000962:Antimalarials / Q000008:administration & dosage / Q000627:therapeutic use*; D037621:Artemisinins / Q000008:administration & dosage / Q000627:therapeutic use*; D000077332:Artesunate; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D006801:Humans; D057230:Limit of Detection; D008288:Malaria / Q000188:drug therapy*; D019265:Spectroscopy, Near-Infrared / Q000379:methods*
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D000077332:Artesunate; D017963:Azithromycin