Artesunate is a natural product in Artemisia apiacea, Acronychiapubescens, and Artemisia carvifolia. It is indicated forthe initial treatment of severe malaria. The World Health Organization recommends Artesunate as a first-line treatment formalaria. The main aim of our study was to develop and validate a simple, accurate, cost-effective UV- VisibleSpectrophotometric method for estimating Artesunate in bulk and pharmaceutical dosage forms. Degradation studies forArtesunate using the UV Spectroscopic method currently not available. The study has extended towards investigating stressdegradation behavior by exposing it to various forced degradation conditions. A solvent was used to develop a method ofArtesunate, methanol, and water in the ratio of 1:9. The λmax was found to be at 248nm. The linearity range was fixed as 10μg/ml-50μg/ml with an R2 of 0.9997. The % recovery was 98-102%, indicating the method's accuracy. The developed method isvalidated as per ICH Q2 guidelines. The LOD and LOQ were 0.435μg/ml and 1.31μg/ml respectively. The % RSD was found tobe well within the limits. The drug showed less stability in oxidative and thermal conditions.

1. Mach H, Volkin DB, Burke CJ, Russell Middaugh C. Ultraviolet absorption spectroscopy. Protein stability and folding.[Chengalva P, kuchana M]. Development and Validation of Ultra Performance Liquid Chromatographic Method for the Simultaneous Estimation of Lamivudine, TenofovirDisoproxil Fumarate, Doravirine and Efavirenz in Bulk and Pharmaceutical Formulations. Indian J PharmSci. 2020 Dec31. 1995:91-114;82(6):1006-14.
2. Chatwal GR, Anand SK. Instrumental method of Chemical Analysis.5th ed.New Delhi: Himalaya Publishing House;2011. p. 2.108-2.110p.
3. Skoog DA, Holler FJ, Nieman TA. Principal of instrumentalanalysis. 5thed, Thomson (Brook/Cole);2004; 378pp.
4. Davidson AG;2002. Ultraviolet-visible absorption spectrophotometry. In:BeckettAH, Stenlake JB, editors, (4thedn). Practical Pharmaceutical chemistry. CBS Publishers and distributors.New Delhi. p. 275-8.
5. Beckett AH, Stenlake JB. Practical pharmaceuticalchemistry.4thed2, CBS Publisher and Distributor New Delhi;2004. p. 275-278p.
6. Patil KM, Bodhankar SL. High-performance thin-layer chromatographic determination of lamotrigine in serum. J Chromatogr B AnalytTechnol Biomed Life Sci. 2005;823(2):152-7 [doi: 10.1016/j.jchromb.2005.06.029][Pubmed:16005693].
7. Connors KA. A textbook of pharmaceutical analysis.3rd ed.John Wiley & Sons;2007. p. 179-185p.
8. Watson DG. A textbook for pharmacy students and pharmaceutical chemists.2nd ed.Elsevier/Churchill Livingstone;2005. p. 89-91p.
9. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of Analysis. 7thed, CBS Publishers New Delhi 1986.159-161p.
10. Dr.Sharma BK. Instrumental method of chemicalanalysis.28th ed.Goel Publishing house;2012. p. S-72-S-74p.
11. Chatwal GR, AnandSK. In:Instrumental methods of chemicalanalysis. 6thed. Mumbai: Mrs. Meena Pandey;2011. Chapter 5.Visible spectrophotometry and colorimetry. p. 2.108-9.
12. PubChem. Artesunate. pubchem.ncbi.nlm.nih.gov. Accessed28 Apr2023. https://pubchem.ncbi.nlm.nih.gov/compound/65664.
13. De Souza JCQ, Chellini PR, Viçosa AL, de Souza MVN, de Oliveira MAL. Simultaneous separation of artesunate and mefloquine in fixed-dose combination tablets by CZE-UV. Anal Methods. 202017Dec;12(47):5709-17[doi: 10.1039/d0ay01755h][Pubmed:33210689].
14. Yabré M, Ferey L, Somé TI, Sivadier G, Gaudin K. Development of a green HPLC method for the analysis of artesunate and amodiaquine impurities using Quality by Design. J Pharm BiomedAnal. 2020Oct;190:113507[doi: 10.1016/j.jpba.2020.113507][Pubmed:32846400].
15. Yabré M, Ferey L, Somé TI, Mercier O, Gaudin K. Green reversed?phase HPLC development strategy: application to artesunate and amodiaquine analysis. J SepSci. 202012Nov;43(24):4390-404[doi: 10.1002/jssc.202000732][Pubmed:33058440].
16. RaginiK, DedaniaZ, DedaniaR, JayP, BrijlalMJ. Spectrophotometric method determination of artesunate and amodiaquine in combined dosage form international journal of research and analytical review. 2018. Dec vol;5(4):781-6.
17. D’hulst A, Augustijns P, Arens S, Van Parijs L, Colson S, Verbeke N, Kinget R. Determination of artesunate by capillary electrophoresis with low UV detection and possible applications to analogues. J ChromatogrSci. 19961Jun;34(6):276-81[doi: 10.1093/chromsci/34.6.276].
18. de SouzaJCQ, Chellini PR, Viçosa AL, de SouzaMVN, de OliveiraMAL. Simultaneous separation of artesunate and mefloquine in fixed-dose combination tablets by CZE-UV. Anal Methods. 2020;12(47):5709-17[doi: 10.1039/d0ay01755h][Pubmed:33210689].
19. Esimone CO, Omeje EO, Okoye FB, Obonga WO, Onah BU. Evidence for the spectroscopic determination of artesunate in dosage form. J Vector Borne Dis.20081Dec;45(4):281-6[Pubmed:19248654].
20. Le Vaillant Y, Brenier C, Grange Y, Nicolas A, Bonnet PA, Massing-Bias LRet al.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. 2012Jun;75(11-12):617-28[doi: 10.1007/s10337-012-2241-5].
21. International conference on harmonisation of technicalrequirements for registration of pharmaceuticals for humanuseIchharmonisedtripartiteguidelinevalidation of analyticalprocedures: text and methodologyQ2. (p. R1) [Internet]. https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.
22. International conference on harmonisation of technicalrequirements for registration of pharmaceuticals for humanuseIchharmonisedtripartiteguidelinestabilitytesting of newdrugsubstances and productsQ1A. (p. R2) [Internet];2003. https://database.ich.org/sites/default/files/Q1A%28r2%29%20guideline.pdf.
23. International conference on harmonisation of technicalrequirements for registration of pharmaceuticals for humanuseIchharmonisedtripartiteguidelinestabilitytesting: photostabilitytesting of newdrugsubstances and products Q1B currentStep 4version[Internet];1996.https://database.ich.org/sites/default/files/Q1B%20guideline.pdf.
24. NogueiraFHA, ReisNFA, Chellini PR, César ID, Pianetti GA. Development and validation of an HPLC method for the simultaneous determination of artesunate and mefloquine hydrochloride in fixed-dose combination tablets. BrazJ PharmSci. 2013;49(4):837-43[doi: 10.1590/S1984-82502013000400024].
25. Van Quekelberghe SA, Soomro SA, Cordonnier JA, Jansen FH. Optimization of an LC-MS method for the determination of artesunate and dihydroartemisinin plasma levels using liquid-liquid extraction. J AnalToxicol. 20081Mar;32(2):133-9[doi: 10.1093/jat/32.2.133][Pubmed:18334096].
26. Gu Y, Li Q, Melendez V, Weina P. Comparison of HPLC with electrochemical detection and LC–MS/MS for the separation and validation of artesunate and dihydroartemisinin in animal and human plasma. J Chromatogr BAnalytTechnol Biomed Life Sci. 200815May;867(2):213-8[doi: 10.1016/j.jchromb.2008.04.019][Pubmed:18468497].
27. Naik H, Murry DJ, Kirsch LE, Fleckenstein L. Development and validation of a high-performance liquid chromatography–mass spectroscopy assay for determination of artesunate and dihydroartemisinin in human plasma. J Chromatogr BAnalytTechnol Biomed Life Sci. 200525Feb;816(1-2):233-42[doi: 10.1016/j.jchromb.2004.11.042][Pubmed:15664355].
28. Saeed MA, Ansari MT, Ch BA, Zaman M. RP-HPLC Method for the determination and quantification of artesunate. J ChromatogrSci. 202021Aug;58(8):695-9[doi: 10.1093/chromsci/bmaa037][Pubmed:32719858].
29. Gaudin K, Kauss T, Lagueny AM, Millet P, Fawaz F, Dubost JP. Determination of artesunate usingreversed?phase HPLC at increased temperature and ELSD detection. J SepSci. 2009Jan;32(2):231-7[doi: 10.1002/jssc.200800437][Pubmed:19101943].
30. Le Vaillant Y, Brenier C, Grange Y, Nicolas A, Bonnet PA, Massing-Bias LRet al.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. 2012Jun;75(11-12):617-28[doi: 10.1007/s10337-012-2241-5].