Journal
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 111, Issue -, Pages 21-27Publisher
ELSEVIER
DOI: 10.1016/j.jpba.2015.02.049
Keywords
Substandard drugs; Counterfeit drugs; NIR spectroscopy; Raman spectroscopy; Accuracy profiles
Categories
Funding
- Belgian Commission de la Cooperation au Developpement
- Walloon Region of Belgium [1117469]
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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). (C) 2015 Elsevier B.V. All rights reserved.
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