Novel spectrophotometric determination of some artemisinin derivatives using alcoholic ammonia solution generated insitu
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Résumé
Background: Dihydroartemisinin (DHA) and Artesunate (ART) are frontline antimalarial drugs for treatment of uncomplicated malaria. A sensitive spectrophotometric method is here developed for the assay of these two antimalarials.
Methods: The reaction is based on the generation of alcohol Ammonia in situ by the action of sodium hydroxide on ammonium Nitrate. The lactone ring of the artemisinin derivatives opens producing a chromogen that can be measured spectrophotometrically; at ?max 350nm and 340nm for DHA and ART respectively.
Results: The absorbance is directly proportional to the drug concentration. Bears law is obey in the range of 5.0-10?g and 5.0 – 80µg/ml for DHA and ART respectively. The correlation coefficient of 0.9997 and 0.9998 respectively. The method was sensitive with molar absorptivity of 2.65 x 103 LMOL-1 and 2.0 x 103 lMOL-CM-1 and Sandell sensitivity of 0.115 and 0.225 ?g/cm2 respectively for DHA and ART. The limit of detection and limit of quantification were determined as per the current ICH guidelines and found to be 0.485 and 0.430/ 1.27 and 1.32µg/ml for DHA and ART respectively. The precision and accuracy are excellent at < 3.00 in all cases.
Conclusion: The method was compared statistically with official pharmacopoeal method via F-test and students T-test and was used to assay DHA and ART tablets procured local which showed good congruence. The aplicability of the method was ascertained by conducting recovery test via standard addition method with results showing no significant interference from excipients.
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Références
WHO Definition of Fake Drugs – WHO, 1998; Dr. Sabine Kopp (1992) Quality and Safety: Medicine Essential Medicines and Pharmaceutical Policies WHO.
Coker H.A.B., Chukuani C. M., and Aina N.D. (2001). The Malaria Scourge Concept in Disease Management. Nigerian Journal of Pharmacy, 32:19-47.
Rozendaal J, (2001) Fake Antimalarial Drugs in Cambodia Lancet 351 (923) 890
Rozendaal (2006) Fake Antimalarial Drugs in Cambodia Lancet 351(923-980)
Newton P.N., Dondorp A., Green M., White Maxay M., White NJ. (2003). Counterfeit Artesunate Antimalaria in Southeast Asia Lancot 362:169.
Newton PN, Green M, Fernandez FM., Day NP. White NJ (2006). Counterfeit Drug Lancet Infectious Disease 6: 602 – 613.
Karunamoothi, K. (2014). The Counterfeit Antimalaria is a crime against humanity: a systematic review of the scientific evidence. Malaria Journal 13(209); 1-13.
WHO (2014) Global Malaria Programme status report on Artemisin resistance
Dondorp et al (2009) Dondorp A.M., (2009) Artemisinin resistance in Plasmodium Falciparum Malaria, N Engl J. Med 2009 361(5); 455 – 67.
Fairhust R.M. and Dondorp A.M. (2016) Artemisinin resistant Plasmodium Falciparum Malaria Microbiol Spectr. 2016; 4(3):10-1128/microbiolspec.1110-0013-2016.
Adegoke O.A., Osoye A. (2011) Derivatization of Artesunate and Dihydroartemisinin for Colorimetric Analysis Using P- Methyl Aminobezaldehye. European Journal of Analytical Chemistry 2011: 6(2): 104 – 113.
Ambroise – Thomas P. (2012). The Tragedy caused by Fake Antimalarial Drugs Mediterranean Journal of Haematology and Infectious Disease, 4:e2012027.
Green M., Mount DL, Wartz R.A, (2001) Authentication of Artemether, Artesunate and Dihydroartemisinin Antimalarial tablets using simple colorimeter. Tropical Medicine International Health 6: (12) 980 – 1982.
Attih, E. E. Usifoh E., and Umoh E. (2015) Novel Spectrophotometric Determination of Artesunate using Vanillin/sulphuric acid reagent. Journal of Chemical and Pharmaceutical Research 7(7) 1050 – 1058.
International Committee for Harmonization (ICH) headlines Q2 (R1). Validation of Analytical Procedure: Text and Methodology, London.