Author(s):
G.Varalakshmi, P.V.Surendra Gupta, P. Bharath, D. Ramachandran
Email(s):
dittakavirc@gmail.com , vgoriparthi09@gmail.com
DOI:
10.52711/0974-360X.2026.00335 
Address:
G.Varalakshmi, P.V.Surendra Gupta, P. Bharath, D. Ramachandran*
Department of Chemistry, University College of Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. Andhra Pradesh, 522510, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 5,
Year - 2026
ABSTRACT:
A precise, accurate and selective stability-indicating reverse phase high performance liquid chromatographic assay method has been developed for the quantitative estimation of Eribulin in Eribulin mesylate in parenteral dosage form. Samples are analysed by means of reverse phase (RP-HPLC) using stationary phase Waters X-Bridge Shield RP18 (150 x 4.6 mm, 3.5µ) and the mobile phase consisted of pH 6.5 phosphate buffer and acetonitrile in the ratio of (70:30 volume/volume). The column temperature was maintained at 40°C and sample cooler temperature was maintained at 5°C, injection volume 10 µL, flow rate 0.8 mL/min and wavelength 200 nm, run time 25 minutes. The retention time of Eribulin mesylate was noted to be 10.45 min respectively. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible and consistent.
Cite this article:
G.Varalakshmi, P.V.Surendra Gupta, P. Bharath, D. Ramachandran. Stability Indicating RP-HPLC Method for Quantitative Estimation of Eribulin Mesylate in Eribulin Mesylate Parenteral Dosage Form. Research Journal Pharmacy and Technology. 2026;19(5):2336-2. doi: 10.52711/0974-360X.2026.00335
Cite(Electronic):
G.Varalakshmi, P.V.Surendra Gupta, P. Bharath, D. Ramachandran. Stability Indicating RP-HPLC Method for Quantitative Estimation of Eribulin Mesylate in Eribulin Mesylate Parenteral Dosage Form. Research Journal Pharmacy and Technology. 2026;19(5):2336-2. doi: 10.52711/0974-360X.2026.00335 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-5-56
REFERENCES:
1. Bai RL. Paull KD. Herald CL et al Halichondrin B and homohalichondrin B, marine natural products binding in the vinca domain of tubulin. Discovery of tubulin-based mechanism of action by analysis of differential cytotoxicity data. Journal of Biological Chemistry. 1991; 266: 15882-15889. https://doi.org/10.1016/S0021-9258(18)98491-7
2. Dubbelman AC. Rosing H. Thijssen B et al Validation of high-performance liquid chromatography-tandem mass spectrometry assays for the quantification of Eribulin (E7389) in various biological matrices. Journal of Chromatography B Analytical Technologies in the Biomedical and Life Sciences. 2011; 879: 1149-1155. https://doi.org/10.1016/j.jchromb.2011.03.021
3. Desjardins C, Saxton P, X Lu S, Li X, Rowbottom C, Wong YN A high-performance liquid chromatography-tandem mass spectrometry method for the clinical combination study of carboplatin and anti-tumor agent Eribulin mesylate (E7389) in human plasma. Journal of Chromatography B Analytical Technologies in the Biomedical and Life Sciences. 2008; 875: 373-382. doi: 10.1016/j.jchromb.2008.09.013
4. EPAR-European public assessment report, http://www.ema.europa.eu/ema/ index.jsp?curl¼pages /medicines/ human/ medicines/ 002084/human_med_001427.jsp&murl¼menus/medicines/medicines.jsp&mid¼ WC0b01ac058001d125 (2011, accessed 9 October 2012).
5. ICH guidelines, for stability testing of new drug substances and products Q1A (R2). 2004.
6. ICH guidelines for validation of analytical procedures: text and methodology Q2 (R1). 2005.
7. Jordan MA. Kamath K. Manna T. et al The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Molecular Cancer Therapeutics. 2005; 4: 1086-1095. doi: 10.1158/1535-7163.MCT-04-0345
8. Kuznetsov G. Towle MJ. Cheng H. et al. Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389. Cancer Research. 2004; 64: 5760-5766. doi: 10.1158/0008-5472.CAN-04-1169
9. Kuznetsov G. TenDyke K and Yu MJ. Anti-proliferative effects of halichondrin B analog Eribulin mesylate against paclitaxel-resistant human cancer cells in vitro. In: AACR-NCI-EORTC international conference: molecular targets and cancer therapeutics. 2007; 22-26. https://doi.org/10.1158/1078-0432.CCR-11-1807
10. Spindeldreier K. Thiesen J. Lipp HP. Kramer I, Physico-chemical stability of Eribulin mesylate containing concentrate and ready-to-administer solutions. Journal of oncology Pharmacy Practice. 2014; 20(3): 183-189. doi: 10.1177/1078155213492449
11. Towle MJ. Salvato KA. Budrow J. et al. In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B. Cancer Research. 2001; 61: 1013-1021. PMID: 11221827
12. Towle MJ. Salvato KA. Wels BF. et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Research. 2011; 71: 496-505. doi: 10.1158/0008-5472.CAN-10-1874
13. Zheng W. Seletsky BM. Palme MH. et al Macrocyclic ketone analogues of halichondrin B. Bioorganic and Medicinal Chemistry Letters. 2004; 14: 5551-5554. https://doi.org/10.1016/j.bmcl.2004.08.069
14. IUPAC Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis, IUPAC Technical Report. Pure and Applied Chemistry. 2002; 74(5): 835-855. https://doi.org/10.1351/pac200274050835
15. Shah BP. Jain S. Prajapati KK. and Mansuri NY. Stability Indicating HPLC Method Development: A Review. International Journal of Pharmaceutical Research Science. 2012; 3(9): 2978-2988. doi: http://dx.doi.org/10.13040/IJPSR.0975-8232.3(9).2978-88
16. Precision of test methods-Repeatability and reproducibility. International Standard ISO 5725. 1986.
17. Snyder LR. Kirkland JJ. and Glajch JL. Completing the Method: Validation and Transfer, in Practical HPLC Method Validation, 1st ed. John Wiley and Sons. New Jersey. 2007. https://doi.org/10.1002/9781118592014
18. Linear calibration using reference material. ISO standard 11095. 1996.
19. Dong MW. Regulatory Aspects of HPLC Analysis: HPLC System and Method Validation, Modern HPLC for Practicing Scientists. 1st ed. John Wiley and Sons. New Jersey. 2006.
20. Araujo P. Key aspects of analytical method validation and linearity evaluation. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences. 2009; 877(23): 2224-2234. doi: 10.1016/j.jchromb.2008.09.030
21. Van Loco J. Elskens M. Croux C. and Beernaert H. Linearity of calibration curves: Use and misuse of the correlation coefficient. Accreditation and Quality Assurance. 2002. doi:10.1007/s00769-002-0487-6
22. Hayashi Y et al. Detection limit estimated from slope of calibration curve: An application to competitive ELISA. Analytical Sciences. 2005; 21(2): 167-169. doi: 10.2116/analsci.21.167
23. Zhao Y et al. Reasons for calibration standard curve slope variation in LC-MS assays and how to address it. Bioanalysis. 2014; 6(11): 1439-1443. doi: 10.4155/bio.14.71.
24. Gonzalez AG. Herrador MA. A practical guide to analytical method validation including measurement uncertainty and accuracy profiles. Trends in Analytical Chemistry. 2007; 26(3) 11: (2007). https://doi.org/10.1016/j.trac.2007.01.009
25. Soni NR. Stability indicating analytical methods (SIAMS). 2018. https://doi.org/10.22376/ijlpr.2023.13.4.P29-P42
26. Blessy M. Patel RD. Prajapati PN. Agrawal YK. Development of forced degradation and stability indicating studies of drugs-A review. Journal of Pharmaceutical Analysis. 2014; 4(3): 159-65. https://doi.org/10.1016/j.jpha.2013.09.003
27. Reynolds DW. Facchine KL. Mullaney JF. Available guidance and best practices for conducting forced degradation studies. Pharmaceutical Technology. 2002; 26: 48-56. doi: 10.1016/j.xphs.2023.09.003
28. Maheswaran R. FDA perspectives: scientific considerations of forced degradation studies in ANDA submissions. Pharmaceutical Technology. 2012; 36: 73-80. https://doi.org/10.22270/jddt.v8i2.1681
29. Heyden YV. Nijhuis A. Smeyers-Verbeke J. Vandeginste BGM. Massart DL. Guidance for Robustness/Ruggedness Tests in Method Validation. 2001; 24: 723-753. doi: 10.1016/s0731-7085(00)00529-x