Volume : 10, Issue : 12, December – 2023

Title:

ANALYTICAL METHOD DEVELOPMENT VALIDATION FOR SIMULTANEOUS DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

Authors :

Roshini Madastu*, Dr.T. Rajesh, Dr.G.Vijaya Kumar, B.Sravanthi

Abstract :

A new simple, accurate, economic, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Artemether and Lumefantrine, in its pure form as well as in pharmaceutical dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5 µ column using a mixture of Methanol: Phosphate Buffer pH-3.6 (30:70v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260nm. The retention time of the Artemether and Lumefantrine was 2.669, 3.855±0.02min respectively. The method produce linear responses in the concentration range of 10-50µg/ml of Artemether and 10-50µg/ml of Lumefantrine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
Keywords: Artemether and Lumefantrine, RP-HPLC, Validation.

Cite This Article:

Please cite this article in press Roshini Madastu et al, Analytical Method Development Validation For Simultaneous Determination Of Artemether And Lumefantrine In Bulk And Pharmaceutical Dosage Form By Using Rp-Hplc, Indo Am. J. P. Sci, 2023; 10 (12).

Number of Downloads : 10

References:

1. Sharma BK. Instrumental methods of chemical analysis, Introduction to analytical chemistry, 23th ed .Goel publishing house meerut, 2004, P12-23.
2. H.H. Willard, L.L. Merritt, J.A. Dean, F.A. Settle. Instrumental methods of analysis, 7th edition, CBS publishers and distributors, New Delhi. 1986, P.518-521, 580-610.
3. John Adamovies, Chromatographic analysis of pharmaceutical, Marcel Dekker Inc. New York, 2nded, P.74, 5-15.
4. Gurdeep Chatwal, Sahm K. Anand. Instrumental methods of chemical analysis, 5th edition, Himalaya publishing house, New Delhi, 2002, P.1.1-1.8, 2.566-2.570
5. D. A. Skoog. J. Holler, T.A. Nieman. Principle of instrumental analysis, 5th edition, Saunders college publishing, 1998, P.778-787.
6. Skoog, Holler, Nieman. Principals of instrumental analysis 5thed, Harcourt publishers international company, 2001, P.543-554.
7. William Kemp. Organic spectroscopy, Palgrave, New York, 2005, P.7-10, 328-330
8. P.D. Sethi. HPLC: Quantitative analysis pharmaceutical formulations, CBS publishers and distributors, New Delhi (India), 2001, P.3-137.
9. 9. Michael E, Schartz IS, Krull. Analytical method development and validation. 2004, P. 25-46.
10. R. Snyder, J. Kirkland, L. Glajch. Practical HPLC method development, 2nded, A Wiley international publication, 1997, P.235, 266-268,351-353.653-600.686-695.
11. Basic education in analytical chemistry. Analytical science, 2001:17(1).
12. Method validation guidelines international Conference on harmonization; GENEVA; 1996.
13. Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New work, 1993; 57:411-28
14. Anthony C Moffat, M David Osselton, Brian Widdop. Clarke’s analysis of drugs and poisons, Pharmaceutical press, London, 2004, P.1109-1110, 1601-1602.
15. Klaus Florey, Analysis profile of drugs substances, Academic press, New York, 2005, P.406-435.