Analytical Method Development and Validation for the Determination of Azacitidine by HPLC

  • Unique Paper ID: 186581
  • PageNo: 1999-2006
  • Abstract:
  • For the determination of AZACITIDINE from its bulk medication, a novel isocratic high-performance liquid chromatographic (HPLC) approach that is straightforward, accurate, fast, and precise was created and validated. Column Zorbax RP C18bonus Column 250cm × 4.6mm, 5µm, with a flow rate of 1.0ml/min, and acetonitrile (75:25) and ammonium acetate buffer as the mobile phase are the optimized parameters. The tailing factor and theoretical plates are within the bounds, and the RT of azacitidine was determined to be 7.5 min. Every parameter was verified in accordance with ICH guidelines and was discovered to be within acceptable bounds. The steyex's slope was used to evaluate the limits of quantification and detection.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{186581,
        author = {SABA YOUSUF and SYED AREEFULLA HUSSAINY},
        title = {Analytical Method Development and Validation for the Determination of Azacitidine by HPLC},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {6},
        pages = {1999-2006},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=186581},
        abstract = {For the determination of AZACITIDINE from its bulk medication, a novel isocratic high-performance liquid chromatographic (HPLC) approach that is straightforward, accurate, fast, and precise was created and validated. Column Zorbax RP C18bonus Column 250cm × 4.6mm, 5µm, with a flow rate of 1.0ml/min, and acetonitrile (75:25) and ammonium acetate buffer as the mobile phase are the optimized parameters. The tailing factor and theoretical plates are within the bounds, and the RT of azacitidine was determined to be 7.5 min. Every parameter was verified in accordance with ICH guidelines and was discovered to be within acceptable bounds. The steyex's slope was used to evaluate the limits of quantification and detection.},
        keywords = {method development, validation, RP-HPLC, and azacitidine.},
        month = {November},
        }

Cite This Article

YOUSUF, S., & HUSSAINY, S. A. (2025). Analytical Method Development and Validation for the Determination of Azacitidine by HPLC. International Journal of Innovative Research in Technology (IJIRT), 12(6), 1999–2006.

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