New Spectrophotometric Method Development and Validation of Lumefantrine
Keywords:
Spectrophotometer, Lumefantrine, Validation, Antimalerial
Abstract
A Simple, sensitive, specific, spectrophotometric method has been developed for the detection of Lumefantrine in pure and Pharmaceutical formulations. The optimum condition for the analysis of the drug was established. Lumefantrine shows maximum absorption at 228 nm and obeyed beers law in the concentration range 10 to 50 µg/ml.
The correlation coefficient was found to be 0.999 and slope of line was found to be 0.0635. The percent S.D. for intra assay precision of the method was found to be 1.85% whereas Inter assay precision was found to be 0.44%. The sample solution was stable up to 24 hours. The assay results were found to be in good agreement with label claim.
The proposed method was simple sensitive, precise, quick and useful for routine quality control.
References
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3.Colussi D, Parisot C, Legay F, Lefevre G, Binding of ar-temether and lumefantrine to plasma proteins and erythrocytes Eur J Pharm Sci. 1999;9:9–16.
4.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.
5.Cesar Ida C, Andrade Nogueira FH, Antonio Pianetti G, Simultaneous determination of artemether and lu-mefantrine in fixed dose combination tablets by HPLC with UV detection, J Pharm Biomed Anal, 2008 Nov. 4; 48(3): 951-4.
6.Da Costa Cesar 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.
7.Annerberg A, Blessborn D, Bergqvist Y, Day N, White NJ, Development and validation of a bioanalytical method using automated solid-phase extraction and LC-UV for the simultaneous determination of lumefantrine and its desbutyl metabolite in plasma, In J Pharm Biomed Anal, 2005, 37 (5) : 1081-8.
8.Lindegardh N Wahajuddin, Singh SP, Jain GK, Determination of lumefantrine in rat plasma by liquid-liquid extraction using LC-MS/MS with electrospray ioniza-tion: assay development, validation and application to a pharmacokinetic study, J. Chromatography B, 2009, 877(11-12): 1133-9.
9.Hodel EM, Zanolari B, Mercier T, Biollaz J, Keiser J, Ol-liaro P, Genton B, Decosterd LA, A single LC-tandem mass spectrometry method for the simultaneous de-termination of 14 antimalarial drugs and their metabolites in human plasma, J Chromatogr B, 2009, 877(10) : 867-86.
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 de-tection, Journal of Pharmaceutical and Biomedical Analysis, 2008; 48(3); 951-954
11.F.W. Fifield and D. Kealey, 5th Edition, Black Well Science Ltd. Principles and Practice of Analytical Chemistry, (2000) pp. 270 – 276.
12.G.C. Hokanson, A Life Cycle Approach to the Validation of Analytical Methods During Pharmaceutical Prod-uct Development, Part – II: Changes and the Need for Additional Validation, Pharm. Tech., 92 -100 (1994).
13.J.M. Green. A Practical Guide to Analytical Method Validation, Anal. Chem. News and Features, 305A – 309A (1996)
14.J. Vessman, Selectivity or Specificity? Validation of Ana-lytical Methods from the Perspective of an Analytical Chemist in the Pharmaceutical Industry, J. Pharm and Biomed. Anal., 14, 867 – 869 (1996).
15.Shrikrishna B. Baokar, B. Shirke, V. Sivanand, G.K. Pratheesh, Analytical method development and validation for esteemation of sildenafil citrate from tablet dosage form by RP-HPLC, Int. J. Res. Phar.Sci. 2(2), 2011, 130-136.
16.Baokar Shrikrishna, Pawar Vinod , Sonawane S.H., High Performance Liquid Chromatographic Method Development and Validation of Cholesterol Inhibitor Drug.Journal of Pharmacy Research, 2011,4(7),2313-2316
17.Baokar Shrikrishna B., Erande R.S., Shaikh S.G. Analytical Method Development and Validation for Estimation of Ezetimibe from Tablet Dosage Form by Using RP-HPLC, Int. J. of Res. in Pharm. and Biomed. Sci., Vol. 2 (2), Apr – Jun 2011, 833-841
Published
2014-05-01
How to Cite
[1]
Shrikrishna, B., Amol, A. and Santosh, U. 2014. New Spectrophotometric Method Development and Validation of Lumefantrine. PharmaTutor. 2, 5 (May 2014), 148-154.
Section
Articles
