A Comprehensive Review on: RP HPLC Method Development and Validation of Fexofenedine Hydrochloride by Central Composite Design (Qbd)

  • Unique Paper ID: 204112
  • Volume: 13
  • Issue: 1
  • PageNo: 1495-1502
  • Abstract:
  • Reverse Phase High Performance Liquid Chromatography (RP-HPLC) is extensively utilized in pharmaceutical analysis because of its high sensitivity, accuracy, and reproducibility. The present review article provides a comprehensive overview of the analytical methods reported for the estimation of Fexofenadine Hydrochloride in pharmaceutical formulations using RP-HPLC techniques. Particular attention has been focused on the implementation of Analytical Quality by Design (AQbD) concepts and Central Composite Design (CCD) for systematic method optimization. Various chromatographic conditions, including selection of mobile phase, column type, flow rate, pH adjustment, and detection wavelength, have been critically examined from published literature. In addition, important validation parameters such as accuracy, precision, linearity, robustness, specificity, limit of detection, and limit of quantification have been reviewed in accordance with International Council for Harmonisation (ICH) guidelines. Literature findings reveal that the application of CCD in RP-HPLC method development enhances analytical performance by improving robustness and minimizing experimental variations. Overall, the reviewed studies demonstrate that CCD-based RP-HPLC methods are reliable, economical, and suitable for routine quality control analysis of Fexofenadine Hydrochloride in pharmaceutical dosage forms. The integration of experimental design approaches into analytical method development offers an efficient and scientific pathway for achieving robust pharmaceutical analytical methods.

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{204112,
        author = {Chaitali Umesh Raut and Mr. Amol N. Lonarkar},
        title = {A Comprehensive Review on: RP HPLC Method Development and Validation of Fexofenedine Hydrochloride by Central Composite Design (Qbd)},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {1495-1502},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=204112},
        abstract = {Reverse Phase High Performance Liquid Chromatography (RP-HPLC) is extensively utilized in pharmaceutical analysis because of its high sensitivity, accuracy, and reproducibility. The present review article provides a comprehensive overview of the analytical methods reported for the estimation of Fexofenadine Hydrochloride in pharmaceutical formulations using RP-HPLC techniques. Particular attention has been focused on the implementation of Analytical Quality by Design (AQbD) concepts and Central Composite Design (CCD) for systematic method optimization. Various chromatographic conditions, including selection of mobile phase, column type, flow rate, pH adjustment, and detection wavelength, have been critically examined from published literature. In addition, important validation parameters such as accuracy, precision, linearity, robustness, specificity, limit of detection, and limit of quantification have been reviewed in accordance with International Council for Harmonisation (ICH) guidelines. Literature findings reveal that the application of CCD in RP-HPLC method development enhances analytical performance by improving robustness and minimizing experimental variations. Overall, the reviewed studies demonstrate that CCD-based RP-HPLC methods are reliable, economical, and suitable for routine quality control analysis of Fexofenadine Hydrochloride in pharmaceutical dosage forms. The integration of experimental design approaches into analytical method development offers an efficient and scientific pathway for achieving robust pharmaceutical analytical methods.},
        keywords = {RP-HPLC, Fexofenadine Hydrochloride, Analytical Quality by Design (AQbD), Central Composite Design (CCD), Method Development, Validation, Pharmaceutical Analysis.},
        month = {June},
        }

Cite This Article

Raut, C. U., & Lonarkar, M. A. N. (2026). A Comprehensive Review on: RP HPLC Method Development and Validation of Fexofenedine Hydrochloride by Central Composite Design (Qbd). International Journal of Innovative Research in Technology (IJIRT), 13(1), 1495–1502.

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