Volume : 13, Issue : 07, July – 2026
Title:
REVERSE PHASE HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF LEFAMULIN IN PURE FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM
Authors :
Dr. Rambabu*, N. Harshitha, P Keerthi, Noushin, Neha Kumari
Abstract :
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Lefamulin, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol and water (45:55% v/v) as the mobile phase at a flow rate of 0.8ml/min, the detection was carried out at 260nm. The retention time of the Lefamulin was 2.359 ±0.02min respectively. The method produce linear responses in the concentration range of 24-120mg/ml of Lefamulin. 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. The method was validated for accuracy, precision, linearity, robustness, ruggedness and LOD & LOQ of standard solution. The developed RP-HPLC method was found to be accurate, precise, linear, and robust and was successful applied to a pharmaceutical tablet formulation for qualitative estimation of Lefamulin in Bulk form and Marketed Pharmaceutical Dosage forms.
Key Words: Lefamulin, RP-HPLC, Method Development, Validation, Accuracy.
Cite This Article:
Please cite this article in press Rambabu et al., Reverse Phase Hplc Method Development And Validation For The Estimation Of Lefamulin In Pure Form And Marketed Pharmaceutical Dosage Form, Indo Am. J. P. Sci, 2026; 13(07).
REFERENCES:
1. https://go.drugbank.com/drugs/DB12825
2. https://pubchem.ncbi.nlm.nih.gov/compound/Lefamulin
3. https://en.wikipedia.org/wiki/Lefamulin
4. Scholars Research Library Der Pharmacia Lettre, 2012, 4 (1):76-86 ISSN 0974-248X USA CODEN: DPLEB4
5. FARMACIA, 2009, Vol. 57, 5 J Pharm Bioallied Sci. 2011 Apr-Jun; 3(2): 310–314. Doi: 10.4103/0975-7406.80766
6. Journal of Pharmaceutical and Biomedical Analysis Volume 21, Issue 2, 1 November 1999, Pages 371–382
7. Tropical Journal of Pharmaceutical Research, October 2009; 8 (5): 449-454 © Pharmacotherapy Group
8. Instrumental Method of Analysis by Rabi Sankar, P-18-6, P-18-3
9. Practical HPLC Method Development by Lloyd R. Snyder et al; 2nd edition, P-503
10. Guidance for industry, Analytical Procedure and Method Validation, U.S. Department of Health and Human Services FDA, August 2000 (www.fda.gov/guidance/index.htm)
11. Y. F. Cheng, T.H. Walter, Z. Lu, P. Iraneta, C. Gendreau, U. D. Neue, J. M. Grassi, J. L. Carmody, J. E. O’ Gara, and R. P. Fisk, LCGC 18(10), 1162 (2000)
12. The United State Pharmacopeia 25/National Formulary 20, Ch. 1225, pg. 2256-2259 (The United State Pharmacopeia Convention, Inc., Rockville, Maryland, 2002)
13. M. V. Gorenstein, J. B. Li, J. Van Antwerp, and D. Chapman, LCGC 12(10), 768-772 (1994)
14. 16. P. M. Young and M. V. Gorenstein, LCGC 12(11), 832-838 (1994)
15. W. J. Warren, W. A. Stanick, M. V. Gorenstein, and P. M. Young, Bio techniques (2), 282-297 (1995)
16. M. E. Swartz, Journal of liquid chromatography, 28(7/8), 1253-1263(2005)
17. M. Swartz and B. Murphy, Am. Lab. 37(3), 22-27 (2005)
18. M. Swartz, Pharm. Formulation quality 6(5), 40-42 (2004)
19. Biomedical Chromatography : BMC 2008 May; 22(5): 469-477
20. Journal of Chromatography .B, Analytical Technologies in the Biomedical and life Sciences. 2008 March 1; 863(2): 258-265. published on 2008 Jan 18
21. Kassen Mussen Nicht fur “Acomplia” Zahlen. Tagesschau.de (2006-10-17). Retrieved on 2007-06-13.
22. Matheson A.J., Noble S., Drugs, Volume 59, Number 4, April 2000, pp. 829-835(7).
23. ICH Q2B: Validation of Analytical Procedure; Methodology (International Conferences on Harmonization of Technical requirements for the registration of Drugs for Human use, Geneva, Switzerland, May 1997)
24. ICH Q2B: Validation of Analytical Procedure; Methodology (International Conferences on Harmonization of Technical requirements for the registration of Drugs for Human use, Geneva, Switzerland, Nov 2003).
25. Muhammad Usman1, 2* and Tauqeer Abbas2, Development and validation of a stability‑indicating RP‑HPLC method for estimation of Lefamulin in pure and pharmaceutical drug products, Future Journal of Pharmaceutical Sciences (2023) 9(1):45.
26. Prabhakara Rao, P. V., Bharath, P., Mastan Ali, S., & Ramachandran, D., (2023), Stability Indicating RP-HPLC Method for Quantification of Lefamulin and Its Impurities in Lefamulin Injection: Pharmaceutical sciences- Analytical chemistry, International Journal of Life Science and Pharma Research, 13(6), P287-P298. https://doi.org/10.22376/ijlpr.2023.13.6.P287-P298.