title: Development, validation and comparison of NIR and Raman methods for the identification and assay of poor-quality oral quinine drops.
abstract: Poor quality antimalarial drugs are one of the public's major health problems in Africa. The depth of this problem may be explained in part by the lack of effective enforcement and the lack of efficient local drug analysis laboratories. To tackle part of this issue, two spectroscopic methods with the ability to detect and to quantify quinine dihydrochloride in children's oral drops formulations were developed and validated. Raman and near infrared (NIR) spectroscopy were selected for the drug analysis due to their low cost, non-destructive and rapid characteristics. Both of the methods developed were successfully validated using the total error approach in the range of 50-150% of the target concentration (20%W/V) within the 10% acceptance limits. Samples collected on the Congolese pharmaceutical market were analyzed by both techniques to detect potentially substandard drugs. After a comparison of the analytical performance of both methods, it has been decided to implement the method based on NIR spectroscopy to perform the routine analysis of quinine oral drop samples in the Quality Control Laboratory of Drugs at the University of Kinshasa (DRC).
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium; Laboratoire d'Analyse des Médicaments, Département de Galénique et d'Analyse des Médicaments, Université de Kinshasa, BP 212, Kinshasa XI, Democratic Republic of Congo.
authors.forename: J K
authors.initials: JK
authors.lastname: Mbinze
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium. Electronic address: pysacre@ulg.ac.be.
authors.forename: P-Y
authors.initials: PY
authors.lastname: Sacré
authors.affiliation: UFR Pharmacie, Faculté des Sciences de Santé, Université d'Abomey Calavi, Bénin.
authors.forename: A
authors.initials: A
authors.lastname: Yemoa
authors.affiliation: Laboratoire d'Analyse des Médicaments, Département de Galénique et d'Analyse des Médicaments, Université de Kinshasa, BP 212, Kinshasa XI, Democratic Republic of Congo.
authors.forename: J
authors.initials: J
authors.lastname: Mavar Tayey Mbay
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium; Rwanda Biomedical Center (RBC)/Medical Procurement and Production Division, P.O. Box 340, Butare, Rwanda.
authors.forename: V
authors.initials: V
authors.lastname: Habyalimana
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium; Laboratoire d'Analyse des Médicaments, Département de Galénique et d'Analyse des Médicaments, Université de Kinshasa, BP 212, Kinshasa XI, Democratic Republic of Congo.
authors.forename: N
authors.initials: N
authors.lastname: Kalenda
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium.
authors.forename: Ph
authors.initials: P
authors.lastname: Hubert
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium.
authors.forename: R D
authors.initials: RD
authors.lastname: Marini
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, 1 Avenue de l'Hôpital, B36, B-4000 Liège, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Ziemons
mesh_terms: D000284:Administration, Oral; D000349:Africa; D000962:Antimalarials / Q000737:chemistry*; D001681:Biological Assay / Q000379:methods*; D019999:Pharmaceutical Solutions / Q000032:analysis* / Q000737:chemistry*; D011786:Quality Control; D011803:Quinine / Q000737:chemistry*; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013059:Spectrum Analysis, Raman / Q000379:methods*
chemical_list: D000962:Antimalarials; D019999:Pharmaceutical Solutions; D011803:Quinine
keywords: Accuracy profiles; Counterfeit drugs; NIR spectroscopy; Raman spectroscopy; Substandard drugs