Simultaneous Estimation and Validation of Artemether and Lumefantrine by UV Spectrophotometry in Tablet
Abstract
A UV spectrophotometric method has been developed for the simultaneous determination of Artemether and Lumefantrine. The spectroscopic method for estimation of Artemether and Lumefantrine employed Area under curve method for analysis using Ethanol as solvent. Artemether has absorbance maxima 253.2 nm and Lumefantrine has absorbance maxima 235.2 nm and both these drugs obey Beer's law in concentration range of 4.24 -67.84 μg/ml for Artemether and 4.68 -28.08 μg/ml for Lumefantrine. The recovery studies ascertained the accuracy of the purposed method and the results were validated as per ICH guidelines. The results were found satisfactory and reproducible. The method was applied successfully for the estimation of Artemether and Lumefantrine in tablet dosage form without the interference of common excipients.
Keywords: Artemether, Lumefantrine; Area under curve; Simultaneous; Estimation
Keywords:
Artemether, Lumefantrine; Area under curve; Simultaneous; Estimation, Artemether, Lumefantrinem, Area under curve, Simultaneous, Estimation
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References
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2. Blessborn D, Römsing S, Annerberg A, Sundquist D, Björkman A, Lindegardh N, Bergqvist Y, Development and validation of an automated solid-phase extraction and liquid chromatographic method for determination of lumefantrine in capillary blood on sampling paper, J Pharm Biomed Analys.2007; 45(2):282-7.
3. César Ida C, Andrade Nogueira FH, Antônio Pianetti G, Simultaneous determination of artemether and lumefantrine in fixed dose combination tablets by HPLC with UV detection, J Pharm Biomed Anal, 2008; 4; 48(3):951-4.
4. Colussi D, Parisot C, Legay F, Lefevre G, Binding of artemether and lumefantrine to plasma proteins and erythrocytes Eur J Pharm Sci. 1999;9:9–16.
5. da Costa César I, Nogueira FH, Pianetti GA, Comparison of HPLC, UV spectrophotometry and potentiometric titration methods for the determination of lumefantrine in pharmaceutical products, J Pharm Biomed Anal, 2008; 48 (1):223-6.
6. Fifield F.W. , Kealey D, 5th Edition, Black Well Science Ltd. Principles and Practice of Analytical Chemistry, (2000) pp. 270 – 276.
7. Hokanson G.C., A Life Cycle Approach to the Validation of Analytical Methods During Pharmaceutical Product Development, Part – II: Changes and the Need for Additional Validation, Pharm. Tech., 92 -100 (1994).
8. Hodel EM, Zanolari B, Mercier T, Biollaz J, Keiser J, Olliaro P, Genton B, Decosterd LA, A single LC-tandem mass spectrometry method for the simultaneous determination of 14 antimalarial drugs and their meta- bolites in human plasma, J Chromatogr B, 2009; 877(10):867-86.
9. International Conference of Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Methodology, Adopted in Geneva (1996).
10. Isabela da Costa César, , Fernando Henrique Andrade Nogueira and Gérson Antônio Pianetti, Simultaneous determination of artemether and lumefantrine in fixed dose combination tablets by HPLC with UV detection, Journal of Pharmaceutical and Biomedical Analysis, 2008; 48(3):951-954
11. Vessman J, Selectivity or Specificity? Validation of Analytical Methods from the Perspective of an Analytical Chemist in the Pharmaceutical Industry, J. Pharm and Biomed. Anal., 1996; 14:867 – 869.
12. Green J.M.. A Practical Guide to Analytical Method Validation, Anal. Chem. News and Features, 305A – 309A (1996)
13. Lindegårdh N Wahajuddin, Singh SP, Jain GK, Determination of lumefantrine in rat plasma by liquid-liquid extraction using LC-MS/MS with electrospray ionization: assay development, validation and application to a pharmacokinetic study, J Chromatogr B, 2009; 877(11-12):1133-9.
14. Sisowath C, Stromberg J, Martensson A, Msellem M, Obondo C, Bjorkman A, Gil JP, In vivo selection of Plasmodium falciparum pfmdr1 86N coding alleles by artemether-lumefantrine (Coartem). J Infect Dis. 2005; 191(6):1014-7.
15. Technical Report Series No. 805. Geneva. 1990.
16. Wahajuddin, Singh SP, Jain GK, Determination of lumefantrine in rat plasma by liquid-liquid extraction using LC-MS/MS with electrospray ionization: assay development, validation and application to a pharmacokinetic study, J Chromatogr B, 2009; 877(11- 12):1133-9.
17. Wegscheider, Validation of Analytical Methods, in: Accreditation and Quality Assurance in Analytical Chemistry, H. Guenzler, Springer (Ed.) Verlag, Berlin (1996). World Health Organization, Practical Chemotherapy of Malaria, W.H.O.
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Mishra M, Mundada A. Simultaneous Estimation and Validation of Artemether and Lumefantrine by UV Spectrophotometry in Tablet. JDDT [Internet]. 15Mar.2021 [cited 1May2024];11(2):16-2. Available from: https://jddtonline.info/index.php/jddt/article/view/4576
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