THE DEVELOPMENT OF LC GENERlC ANALYTICAL METHODS TO FIGHT COUNTERFEIT NSAIDS USING DESIGN SPACE OPTIMISATI0N STRATEGY UNIVERSITY of LIEGE SBSP 2012, Blankenberge May 07-08, 2012 J. Mbinze Kindenge , P. Lebrun, B. Debrus, A. Dispas, R.D. Marini, Ph. Hubert
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THE DEVELOPMENT OF LC GENERlC ANALYTICAL METHODS TO FIGHT
COUNTERFEIT NSAIDS USING DESIGN SPACE OPTIMISATI0N STRATEGY
UNIVERSITY of LIEGE
SBSP 2012, Blankenberge May 07-08, 2012
J. Mbinze Kindenge, P. Lebrun, B. Debrus, A. Dispas, R.D. Marini, Ph. Hubert
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Agenda
1. Introduction
2. Objectives
3. Methodology
4. Results
5. Conclusion
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A picture of results published from a large scale study was challenging.
1/3 of antimalarial medicines sampled in three African nations were found to be substandard or counterfeit.
80 % of counterfeit reported in some African’s regions.
For the 4-aminophenol, a one-level calibration is used 0.1% of 4-aminophenol (0.5 µg/mL) in 100% paracetamol (500 µg/mL) LLOQ : 0.1 µg/mL
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Coded specialities (brands)
Declared amount Content (mean% ± S.D.; n = 3)
Specifications (%)
(European Medicines Agency)
Paracetamol Caffeine Ibuprofen
A 325 mg
98.4 ± 0.41 30 mg
90.7 ± 1.49 200 mg
103.7 ± 0.74
95.0 – 105.0
B 325 mg
100.0 ± 0.35 40 mg
94.7 ± 0.63 200 mg
103.0 ± 0.58
C 200 mg
90.4 ± 0.22 40 mg
85.2 ± 0.79 400 mg
91.1 ± 0.73
D 325 mg
78.2 ± 0.39 40 mg
74.5 ± 0.44 400 mg
77.9 ± 0.15
E 325 mg
78.9 ± 0.28 40 mg
75.9 ± 0.31 400 mg
80.6 ± 0.35
Quantification
4. Results
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Counterfeit of medicines is a crucial problem of public health. It is so important to develop analytical tools to support decision making of the legal authorities.
The main objective of this work was to develop generic methods able to trace, screen and determine multiple NSAIDs and common associated molecules, in order to detect potential counterfeit drugs.
DS strategy enables robust method development, confirmed by successful transfer method. these validated methods can easily used in quality control laboratory.
5. Conclusion
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Transfer/ Development of other methods are currently carried out with view on advantages allowing use them efficiently and continuously.
5. Conclusion
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Thanks for your attention
• See our publications at: http://orbi.ulg.ac.be/; and our posters
Thanks to : • Prof. Ph. Hubert • Dr. R. Marini • The Belgian University Development Cooperation (CUD) • The Walloon Project PPP (Convention OPTIMAL DS N°917007)