Validated Spectrophotometric Determination of Artesunate and Dihydroartemisinin Using Anisaldehyde/Sulphuric acid Reagent
Article Sidebar
Main Article Content
Abstract
Background: To check the widespread manufacture and distribution of counterfeit Artemisinin derivatives in Nigeria, a simple sensitive spectrophotometric method has been developed.
Method: The method was based on the nucleophilic reaction of Artesunate (ART) and Dihydroartemisinin (DHA) with Anisaldehyde/Sulphuric acid reagent, monitored spectrometrically at ?max500nm and 490nm for ART and DHA respectively.
Results: Beers Law was obeyed within the range of 5.0 - 50µg/ml and 5.5 - 60µg/ml for ART and DHA respectively. The linear calibration curve determined through the least square method had regession equation of A= mx + c with the correlation coefficient of 0.996 and 0.9980 for ART and DHA respectively. Sensitivity parameters – Molar Absorptivity and Sandell Sensitivity were determined with the value 2.28×104 and 2.25 ×104, and 0.83 and 0.59 µg/cm2 for ART and DHA respectively. Limits of Detection (LVD) and Qualification (LOQ) determined as per the current international committee on Harmonization (ICH) were found to be 0.37 and 0.30 for ART and DHA respectively. The inter-day and intraday precision and accuracy were ? 2.9. The method was used to assay commercial tablets produced for local Pharmacies in Uyo, Nigeria, and was statistically compared with an official method via student T test and various F tests.
Conclusion: A simple, sensitive and reproducible method based on the nucleophilic reaction of the drugs with Anisaldehyde/Sulphuric acid has been developed for the determination of ART and DHA in tablets distributed in local pharmacies in Uyo metropolis.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
Rozendaal J. Fake Anti- malaria drug in Cambodia. Lancet 2001, 375, (923) 890.
Newton P., Proux S., Green M. D. Smithius, Rozendaal et al (2001), Fake Artesunate in Southeast Asia. Lancet 373:1948 - 1950
Lon C. T., Tsuyuoka R, Phanouvona S., Nivanna N., Socheat D et al counterfeit and substandard Anti-malarial drugs in Cambodia. Trans R. 80c of Trop. Med. Hyg. 2006 100: 1019 – 1024.
Karunamoothi, K., The counterfeit anti-malaria is a crime against humanity: a systematic review of the scientific evidence. Malaria Journal. 2014; 13: 209, 1 – 13
Atemkong M. A., Deccock K., Plaizer- Vercarmmen J., Quality control of active ingredient in artemisinin derivative antimalarial is within Kenya and DR Congo. Trop. Med int. Health. 2007;12: 68 – 742.
Bate R, Coticelli P., Tren R., and Attarran A Antimalaria drug quality in the most severely mal… parts of Africa – a six country study., Plus ONE Journal. 2008; 3(5) e2132.
Dondorp A. M., Nosten F., Poravuth Y. I., Dabashish D., Taming J et al Aretemisinin resistance in P. falciparum malaria. N. Engl Journal of Medicine. 2009. 361(6) 455 – 467
Fairhust R. M., and Dondorp Artemisinin resistant P. falciparum malaria microbiol.Spectr.4 (3).Doi 10 1128/ microbial spec. 2016; E 110 – 0013.
World Health Organisation, Global Malaria Program, station report on artemisnin resistance, September 2014.
Ambroise- Thomas The Tragedy Caused by fake Antimalarial Drugs. Mediterranean Journal of Hematology and Infectious disease. 2013; 4 (1)e2012027.
Green, M. D., Modent D. C, Wurt R. A. Authentication of Artemether, Artesunate and Dihydroartemisinin Antimalaria tablets using colorimeter method. Tropical Medicine and International Health, 2001, 280 – 982
Attih E., Usifoh C., Ambe D., and Eseyin O.,( 2015), Qualitative titrimetric and spectrophotometric determination of Dihydroartemisin based on Redox reaction with Ceric Ammonium Sulphate. Journal of Chemical and Pharmaceutical Research, 7(6): 732 – 738
Adegoke OA. and Oseye AO. Derivatisation of Artesunate and Dihyroartemisinin for Colorimetric Analysis using p- Dimethyl-1-aminobenzaldehyde, E Journal of Analytical Chemistry. 2011; 6(2): 104 – 113
International Committee for Harmonization (ICH) guidelines Q2(R1), validation of Analytical procedure : Text and Methodology, London. 2005