DEVELOPMENT AND VALIDATION OF A SIMPLE AND PRECISE HPLC METHOD FOR THE ESTIMATION OF KETOROLAC TROMETHAMINE AND ITS APPLICATION IN MATRIX TABLET FORMULATION

  • Unique Paper ID: 179701
  • PageNo: 8141-8148
  • Abstract:
  • A simple, rapid, accurate, and precise isocratic high-performance liquid chromatography (HPLC) method was developed and validated for the quantitative estimation of Ketorolac Tromethamine (KT) in matrix formulations. The chromatographic separation was performed using a Kintex C8 column (250 mm × 4.6 mm, 5 µm) at room temperature with a mobile phase consisting of Methanol: Acetonitrile: MKP and MSP in the ratio of 5:15:80 (v/v), delivered at a flow rate of 1.0 mL/min. Detection was carried out using a photodiode array (PDA) detector at a wavelength of 319 nm. The retention time of KT was observed at 2.20 minutes. The developed method showed excellent linearity over a concentration range of 20% to 120%, with a correlation coefficient (R²) of 0.9994. System suitability parameters and percentage assay results (ranging from 98% to 100%) were within acceptable limits. The percentage recovery for KT was found to be between 98% and 99.5%, confirming the method's accuracy. All validation parameters, including specificity, precision, linearity, accuracy, and robustness, complied with ICH guidelines. The results indicate that the developed HPLC method is reliable and suitable for routine analysis of Ketorolac Tromethamine in pharmaceutical matrix formulations.

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{179701,
        author = {Pratiksha R. Meshram and Ajinkya V. Gulhane and Aachal S. Chimkar and Dr. Anil P. Dewani and Manisha D. Kitukale and Dr. Anil V. Chandewar},
        title = {DEVELOPMENT AND VALIDATION OF A SIMPLE AND PRECISE HPLC METHOD FOR THE ESTIMATION OF KETOROLAC TROMETHAMINE AND ITS APPLICATION IN MATRIX TABLET FORMULATION},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {11},
        number = {12},
        pages = {8141-8148},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=179701},
        abstract = {A simple, rapid, accurate, and precise isocratic high-performance liquid chromatography (HPLC) method was developed and validated for the quantitative estimation of Ketorolac Tromethamine (KT) in matrix formulations. The chromatographic separation was performed using a Kintex C8 column (250 mm × 4.6 mm, 5 µm) at room temperature with a mobile phase consisting of Methanol: Acetonitrile: MKP and MSP in the ratio of 5:15:80 (v/v), delivered at a flow rate of 1.0 mL/min. Detection was carried out using a photodiode array (PDA) detector at a wavelength of 319 nm. The retention time of KT was observed at 2.20 minutes. The developed method showed excellent linearity over a concentration range of 20% to 120%, with a correlation coefficient (R²) of 0.9994. System suitability parameters and percentage assay results (ranging from 98% to 100%) were within acceptable limits. The percentage recovery for KT was found to be between 98% and 99.5%, confirming the method's accuracy. All validation parameters, including specificity, precision, linearity, accuracy, and robustness, complied with ICH guidelines. The results indicate that the developed HPLC method is reliable and suitable for routine analysis of Ketorolac Tromethamine in pharmaceutical matrix formulations.},
        keywords = {Ketorolac Tromethamine, HPLC, Method Development, Matrix Formulation, Assay, Recovery.},
        month = {May},
        }

Cite This Article

Meshram, P. R., & Gulhane, A. V., & Chimkar, A. S., & Dewani, D. A. P., & Kitukale, M. D., & Chandewar, D. A. V. (2025). DEVELOPMENT AND VALIDATION OF A SIMPLE AND PRECISE HPLC METHOD FOR THE ESTIMATION OF KETOROLAC TROMETHAMINE AND ITS APPLICATION IN MATRIX TABLET FORMULATION. International Journal of Innovative Research in Technology (IJIRT), 11(12), 8141–8148.

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