EThe oral quinine drops were prepared -Raman and NIR spectroscopy methods were developed and validated -The methods were applied for analysis the real and substandard drugs. Poor quality antimalarial drugs are one of the public's major health problems in Africa. The 14 depth of this problem may be explained in part by the lack of effective enforcement and the 15 lack of efficient local drug analysis laboratories. To tackle part of this issue, two 16 spectroscopic methods with the ability to detect and to quantify quinine dihydrochloride in 17 children's oral drops formulations were developed and validated. Raman and Near Infrared 18 (NIR) spectroscopy were selected for the drug analysis due to their low cost, non-destructive 19 and rapid characteristics. Both of the methods developed were successfully validated using 20 the total error approach in the range of 50-150% of the target concentration (20% W/V) 21 within the 10% acceptance limits. Samples collected on the Congolese pharmaceutical market 22 were analyzed by both techniques to detect potentially substandard drugs. After a comparison 23 of the analytical performance of both methods, it has been decided to implement the method 24 based on NIR spectroscopy to perform the routine analysis of quinine oral drop samples in the 25 Quality
Introduction 31Malaria remains one of the most rampant illnesses worldwide and is one of the main 32 causes of child mortality in developing countries [1][2]. The treatment of uncomplicated 33 malaria is based on conventional antimalarial drugs (e.g. chloroquine, artemisinin derivatives, 34 atovaquone, etc.). These drugs are essentially used as combinations due to the growing 35 resistance observed with single-drug therapy [3]. However, quinine is still recommended 36 alone in the treatment of severe and/or cerebral malaria attacks as well as for chloroquine-37 resistant falciparum malaria [4]. Four quinine based dosage forms are found on the 38 pharmaceutical market in DRC: tablets (250 and 500 mg), ampuls (250 and 500 mg/2mL), 39 syrup (100 mg /mL) and oral drops (200 mg /mL). The last three dosage forms are the most 40 used with 0-5 year old children. In 2009, the Health Ministry of the DRC warned citizens 41 against quinine oral drops "Quinizen 20%" that were found to have been counterfeit and 42 substandard [5]. 43Poor quality (substandard, counterfeit and degraded) or substandard/spurious/falsely-44 labelled/falsified/counterfeit anti-malarial drugs constitute a major public health concern 45 especially in developing countries where the pharmaceutical market is poorly regulated and 46The use such drugs may lead to therapeutic failure, death and reinforce drug resistance [7, 8].
t vVibrational spectroscopic techniques, such as Near Infrared (NIR) and Raman 49 spectroscopies are frequently used techniques in the field of quantitative drug analysis [9-11] 50 and in the fight against counterfeit drugs [12][13][14][15]. These techniques have the advantages of 51 being non-destructive, fast, requiring little or no sample...
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