International Journal of Medical and All Body Health Research  |  e-ISSN: 2582-8940  |  Double-Blind Peer Review  |  Open Access  |  CC BY-NC-SA 4.0

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     2026:7/4

International Journal of Medical and All Body Health Research

e-ISSN: 2582-8940 | Open Access

RP-HPLC Method Development and Validation for the Quantitative Determination of Ruxolitinib in Pure Form and Marketed Pharmaceutical Dosage Form

Article Information

Volume / Issue5 / 2 (June-December 2024)
Pages15-21
AccessOpen Access

Publication Timeline

  • Received02 March 2024
  • Accepted03 April 2024

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Abstract

A novel, simple, accurate, precise, sensitive and specific analytical RP-HPLC method was developed and validated for the quantitative estimation of Ruxolitinib in bulk drugs and pharmaceutical dosage form. Chromatographic separation was achieved on an Symmetry ODS C18 (4.6×250mm, 5µm) analytical column using mobile phase composition of methanol and Phosphate Buffer in ratio of (35: 65 v/v) that was set at a flow rate of 1.0μl/min with detection of 235 nm. The retention time of Ruxolitinib was found to be 3.006min. The drug was analyzed by following the guidelines of International conference on Harmonization (ICH). This drug showing linearity in the concentration range of 6-14µg/ml and the correlation coefficient showing R2 = 0.9996. The % Recoveries showing within the limits. The presentation of the method was validated according to the present ICH guidelines for accuracy, precision and robustness, Linearity, limit of quantification, limit of detection linearity. 

References

  1. DrugBank. Ruxolitinib. Available from: https://go.drugbank.com/drugs/DB08877. Accessed: December 15, 2023. [Google Scholar][Crossref]
  2. PubChem. Ruxolitinib. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Ruxolitini b. Accessed: December 15, 2023. [Google Scholar][Crossref]
  3. Wikipedia. Ruxolitinib. Available from: https://en.wikipedia.org/wiki/Ruxolitinib. Accessed: December 15, 2023. [Google Scholar][Crossref]
  4. Snyder R, Kirkland J, Glajch L. Practical HPLC Method Development. 2nd ed. John Wiley and Sons International publication; 2011. [Google Scholar][Crossref]
  5. Ashutoshkar S. Pharmaceutical Drug Analysis. 2nd ed. New Age International Private Limited Publishers; 2005. p. 452-474. [Google Scholar][Crossref]
  6. Beckett H, Stenlake JB. Practical Pharmaceutical Chemistry. 4th ed. C.B.S. Publishers and Distributors; New Delhi. p. 1-9, 157-167. [Google Scholar][Crossref]
  7. Williard HH, Merit LL, Dean FA, Settle FA. Instrumental Methods of Analysis. 6th ed. C.B.S. Publishers and Distributors; New Delhi. p. 430-440, 495-International Journal of Medical and All Body Health Research www.allmedicaljournal.com 504, 529-545. [Google Scholar][Crossref]
  8. Sharma BK. Instrumental Methods of Chemical Analysis. Meerut: GOEL Publishing House; p. 286-300. [Google Scholar][Crossref]
  9. Kealey D, Haines PJ. Instant Notes on Analytical Chemistry. BIOS Scientific Publishers Limited; UK; 2002. p. 6-7. [Google Scholar][Crossref]
  10. Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. 5th ed. Mumbai: Himalaya Publishing House; 2005. p. 2.566. [Google Scholar][Crossref]
  11. Swartz ME. Journal of Liquid Chromatography. 2005; 28(7/8):1253-1263. [Google Scholar][Crossref]
  12. Journal of Chromatography B. Analytical Technologies in the Biomedical and Life Sciences. 2008 Mar 1; 863(2):258-265. [Google Scholar][Crossref]
  13. International Conference on Harmonization. Harmonized Tripartite Guideline. Validation of Analytical Procedures. Text and Methodology. Q2 (R1). November 2005. [Google Scholar][Crossref]
  14. International Conference on Harmonization (ICH). Validation of Analytical Methods: Definitions and Terminology. ICH Q2A. 1994. [Google Scholar][Crossref]
  15. Green JM. A practical guide to analytical method validation. Anal Chem News & Features. 1996 May 1; 305a–309a. [Google Scholar][Crossref]
  16. Winslow PA, Meyer RF. Defining a master plan for the validation of analytical methods. J Validation Technology. 1997; 361-367. [Google Scholar][Crossref]
  17. AOAC Peer-Verified Methods Program. Manual on Policies and Procedures. Arlington, VA, USA; 1998. [Google Scholar][Crossref]
  18. Patil R. J of Chromatographia. 2008; 67:575. [Google Scholar][Crossref]
  19. Baht and Leena. J of Liq Chrom. 2007; 30:309. [Google Scholar][Crossref]
  20. Williard HH, Merit LL, Dean FA, Settle FA. Instrumental Methods of Analysis. 7th ed. C.B.S. Publishers; New Delhi; 2002. [Google Scholar][Crossref]
  21. Menon GN, White LB. Department of Analytical Research, Abbott Laboratories (PubMed-index for MEDLINE). [Google Scholar][Crossref]
  22. Food and Drug Administration (FDA). Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation. Federal Register (Notices). 2000; 65(169):52776–52777. [Google Scholar][Crossref]
  23. Vibha G, et al. Development and validation of HPLC method - a review. Int Res J Pharm Appl Sci. 2012; 2(4):22-23. [Google Scholar][Crossref]
  24. Bliesner DM. Validating Chromatographic Methods. John Wiley & Sons Inc.; 2006. p. 88-92. [Google Scholar][Crossref]
  25. Validation of Analytical Procedures: Methodology. ICH-Guidelines Q2B, Geneva. 1996. (CPMP/ICH/281/95). [Google Scholar][Crossref]
  26. Gupta V, et al. Development and validation of HPLC method - A Review. Int Res J Pharm Appl Sci. 2012; 2(4):17-25. [Google Scholar][Crossref]
  27. Bhardwaj SK, et al. A Review: HPLC Method Development and Validation. Int J Anal Bioanal Chem. Accepted Nov 20, 2015. [Google Scholar][Crossref]
  28. Chromacademy. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC. [Google Scholar][Crossref]
  29. Sonawane LV. Bioanalytical Method Validation and Its Pharmaceutical Application- A Review. Pharm Anal Acta. 2014; 5(3), For Drug Evaluation and Research (CDER) Reviewer Guidance. [Google Scholar][Crossref]
  30. ICH. Validation of Analytical Procedures: Text and Methodology Q2(R1). [Google Scholar][Crossref]
  31. Biswal S, Mondal S, Mondal P. A New Stability Indicating High Performance Liquid Chromatography Method for the Estimation of Ruxolitinib in Bulk and Tablet Dosage Form. Pharm Methods. 2019; 10(2):53-57. [Google Scholar][Crossref]
  32. Tabassum R, Rizwan SH. Stability Indicating Analytical Method Development and Validation for the Estimation of Ruxolitinib in Bulk and Pharmaceutical Dosage Form Using UPLC. Int J Pharm Pharm Sci. 2023; 15(2):40-46. [Google Scholar][Crossref]
  33. Sai Kiran N, Parameshwar H, Jithan AV. Method Development and its Validation for Antineoplastic Agents (Ruxolitinib) by RP-HPLC. Int J Allied Med Sci Clin Res. 2022; 10(2):268-273. [Google Scholar][Crossref]
  34. Di Michele A, Schoubben A, Varfaj I, D’Arpino A, Mercolini L, Sardella R, et al. Improved Achiral and Chiral HPLC-UV Analysis of Ruxolitinib in Two Different Drug Formulations. Separations. 2020; 7(3):47. Available from: https://doi.org/10.3390/separations7030047.Copyright and License © The Author(s). Authors retain the copyright of their published articles. This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution Non Commercial-Share A like 4.0 International (CC BY-NC-SA 4.0) License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. [Google Scholar][Crossref]

How to Cite

Prathusha, J., Ramakrishna, U., Poojitha, K., Amulya, K., & Radhikareddy, N. (2024). RP-HPLC Method Development and Validation for the Quantitative Determination of Ruxolitinib in Pure Form and Marketed Pharmaceutical Dosage Form. International Journal of Medical and All Body Health Research, 5(2), 15-21.

Prathusha, J, et al. "RP-HPLC Method Development and Validation for the Quantitative Determination of Ruxolitinib in Pure Form and Marketed Pharmaceutical Dosage Form." International Journal of Medical and All Body Health Research, vol. 5, no. 2, 2024, pp. 15-21.

Prathusha, J., Ramakrishna, U., Poojitha, K., Amulya, K. and Radhikareddy, N. (2024) 'RP-HPLC Method Development and Validation for the Quantitative Determination of Ruxolitinib in Pure Form and Marketed Pharmaceutical Dosage Form', International Journal of Medical and All Body Health Research, 5(2), pp. 15-21.

Prathusha J, Ramakrishna U, Poojitha K, Amulya K, Radhikareddy N. RP-HPLC Method Development and Validation for the Quantitative Determination of Ruxolitinib in Pure Form and Marketed Pharmaceutical Dosage Form. International Journal of Medical and All Body Health Research. 2024;5(2):15-21.

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