Simultaneous determination of artesunate and amodiaquine in fixed-dose combination by a RP-HPLC method with double UV detection: Implementation in interlaboratory study involving seven African National Quality Control Laboratories

Chromatographia

Volumn 75, Issue 11-12, 2012, Pages 617-628

  Le Vaillant, Y ^a   Brenier, C ^a   Grange, Y ^a   Nicolas, A ^a   Bonnet, P A ^a   Massing Bias, L R ^b   Rakotomanga, P ^c   Koumare B ^d   Mahly, A ^e   Absi, M ^f   Ciss, M ^g   Loueslati, M H ^h   Chauvey, D ^a  

^a AFSSAPS   (France)

^b Laboratoire National de Contrôle de Qualité des Médicaments et D'expertise   (Cameroon)

^c Agence du Médicament de Madagascar BP   (Madagascar)

^d Division Hygiène et Assainissement   (Mali)

^e Laboratoire National de Contrôle de Qualité des Médicaments   (Morocco)

^f Laboratoire National de Santé Publique et D'expertise   (Niger)

^g Laboratoire National De Contrôle Des Médicaments   (Senegal)

^h Laboratoire National de Contrôle de Qualité des Médicaments   (Tunisia)

Author keywords

Artesunate and amodiaquine; Drug combination; RP HPLC UV; Simultaneous determination

Indexed keywords

ACETONITRILE; AMODIAQUINE; ARTESUNATE; POTASSIUM DIHYDROGEN PHOSPHATE; SILICA GEL;

AQUEOUS SOLUTION; ARTICLE; DRUG RETENTION; DRUG STABILITY; DRUG STRUCTURE; HYDROPHOBICITY; PH; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; TABLET; ULTRAVIOLET SPECTROSCOPY;

EID: 84864700170     PISSN: 00095893     EISSN: 16121112     Source Type: Journal    
DOI: 10.1007/s10337-012-2241-5     Document Type: Article

References (33)

1. World Health Organization (2010) Guidelines for the treatment of Malaria, 2nd edn. http://whqlibdoc.who.int/publications/2010/9789241547925-eng.pdf. Accessed 06 Mar 2012
2. World Health Organization (2011) Fact sheet N-94. http://www.who.int/ mediacentre/factsheets/fs094/en/.Accessed 06 Mar 2012
3. World Health Organization (2010) Good procurement practices for artemisinin-based antimalarial medicines. http://whqlibdoc.who.int/publications/ 2010/9789241598927-eng.pdf. Accessed 06 Mar 2012
4. Chekem L, Wierucki S (2006) Med Trop 66:602-605
5. World Health Organization (2010) World Malaria Report. http://www.who.int/malaria/world-malaria-report-2010/worldmalariareport2010.pdf. Accessed 06Mar 2012
6. Mutabingwa TK (2005) Acta Trop 95:305-315. doi:10.1016/j.actatropica. 2005.06.009
7. Adjuik M, Agnamey P, Babiker A, Borrmann S, Brasseur P, Cisse M, Cobelens F, Diallo S, Faucher JF, Garner P, Gikunda S, Kremsner PG, Krishna S, Lell B, Loolpapit M, Matsiegui PB, Missinou MA, Mwanza J, Ntoumi F, Olliaro P, Osimbo P, Rezbach P, Some E, Taylor WRJ (2002) Lancet 359:1365-1372. doi: 10.1016/S0140-6736(02)08348-4
8. Olliaro P, Vaillant M et le groupe d'étude de l'ASAQ (2009) Revue d'Epidémiologie et de santé Publique 57:S45. doi: 10.1016/j.respe.2009.02.156
9. USAID report (2009) Survey of the Quality of Selected Antimalarial Medicines Circulating in Madagascar, Senegal, and Uganda. http://www.usaid.gov/ our-work/global-health/hs/publications/qamsa-report-1109.pdf. Accessed 06 Mar 2012
10. Bate R, Coticelli P, Tren R, Attaran A (2008) PLoS 3:e2132. doi: 10.1371/journal.pone.0002132
11. International Pharmacopoeia (2011) 4th edn. Amodiaquine hydrochloride
12. Draft revision for International Pharmacopoeia (2011) Artesunate. Draft for comment. Working document QAS/11.447. http://www.who.int/medicines/areas/ quality-safety/quality-assurance/Artesunate-mono-QAS11-447-10082011.pdf. Accessed 06 Mar 2012
13. Draft revision for International Pharmacopoeia (2009) Artesunate tablets. Draft for comment. Working document QAS/09.341. http://www.who.int/medicines/ services/expertcommittees/pharmprep/Artesunatetablets.pdf. Accessed 06 Mar 2012
14. Revised Draft proposal for International Pharmacopoeia (2009) Amodiaquine tablets. Revised Draft for comment. Working document QAS/07.223/Rev.3. http://www.who.int/medicines/services/expertcommittees/pharmprep/ Amodiaquine-tablets.pdf. Accessed 06 Mar 2012
15. United States Pharmacopeia 34 (2011) Amodiaquine and Amodiaquine hydrochloride tablets
16. United States Pharmacopeia 34 (2010) Authorized USP's non-US standards. Version 1: Artesunate tablets. http://www.usp.org/sites/default/files/usp-pdf/ EN/nonUSStandards/artesunatetablets. pdf. Accessed 06 Mar 2012
17. Phadke MU, Jadhav VK, Jadhav RK, Dave SS, Patil DS (2008) Chromatographia 68:1003-1007. doi:10.1365/s10337-008-0800-6
18. Okwelogu C, Clark B, de Matas M, Ifudu D, Igwilo C, Silva B, York P (2010) Int J Pharm 387:19-25. doi:10.1016/j.ijpharm.2009.11.028
19. Lai CS, Nair NK, Mansor SM, Olliaro PL, Navaratnam V (2007) J Chromatogr B 857:308-314. doi:10.1016/j.jchromb.2007.07.037
20. Lai CS, Nair NK, Muniandy A, Mansor SM, Olliaro PL, Navaratnam V (2009) J Chromatogr B 877:558-562. doi:10.1016/j.jchromb.2008.12.037
21. Lindegardh N, Dondorp AM, Singhasivanon P, White NJ, Day NPJ (2007) J Pharm Biomed Anal 45:149-153. doi:10.1016/j.jpba.2007.04.030
22. Stringham RW, Lynam KG, Mrozinski P, Kilby G, Pelczer I, Kraml C (2009) J Chromatogr A 1216:8918-8925. doi:10.1016/j.chroma.2009.10.056
23. Chen X, Deng P, Dai X, Zhong D (2007) J Chromatogr B 860:18-25. doi:10.1016/j.jchromb.2007.09.040
24. ICH Q2R1 (2005) Text on Validation of Analytical Procedures: text and methodology, ICH harmonized tripartite guidelines. http://www.ich.org/products/ guidelines/quality/article/quality-guidelines.html. Accessed 06 Mar 2012
25. European Medicines Agency CPMP/QWP/122/02 rev 1 corr (2003) Guideline on stability testing: stability testing of existing active substances and related finished products. http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2009/09/WC500003466.pdf. Accessed 06 Mar 2012
26. Ellie C, Breton D, Brezillon C, Buret D, Camarade M, Castel F, Cosledan S, Coupe J, Crespo N, Duguet A, Laschi A, Laviron S, Menier I, Mennweg V, Nolleau V, Zanzi V (2007) STP Pharma Pratiques 17:89-99
27. Augustijns P, D'Hulst A, Van Daele J, Kinget R (1996) J Pharm Sci 85:577-579
28. Hawley SR, Bray PG, O'Neill PM, Park BK, Ward SA (1996) Biochem Pharmacol 52:723-733
29. European Pharmacopoeia (2012) Chromatographic separation techniques, chap 2.2.46, 7th edn
30. Neue UD, Marchand DH, Snyder LR (2006) J Chromatogr A 1111:32-39. doi:10.1016/j.chroma.2006.01.104
31. Gritti F, Guiochon G (2008) J Chromatogr A 1212:35-40. doi: 10.1016/j.chroma.2008.09.113
32. ISO/IEC Standard 17043 (2010) Conformity assessment General requirements for proficiency testing
33. ISO/IEC Standard 5725-2 (1994) Accuracy (trueness and precision) of measurement methods and results