STABILITY INDICATING METHOD DEVELOPMENT & VALIDATION OF BILASTINE BY RP-HPLC METHOD

  • Unique Paper ID: 188761
  • Volume: 12
  • Issue: 7
  • PageNo: 3529-3537
  • Abstract:
  • A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Bilastine in bulk form and marketed formulation. Separation of Bilastine was successfully achieved on a Symmetry C18, 250 mm x 4.6 mm i.d.5µm particle size column in an isocratic mode of separation utilizing Acetonitrile and Water in the ratio of 40:60% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 245nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 6-14mcg/mL for Bilastine. The correlation coefficient was found to be 0.9983 for Bilastine. The LOD and LOQ for Bilastine were found to be 0.05µg/mL and 0.15µg/mL respectively. The proposed method was found to be good percentage recovery for Bilastine, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.

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{188761,
        author = {Madhu Chhanda Mishra and Pragati Ranjan Satpathy and Nilima Shukla and Jagannath Prasad Mishra},
        title = {STABILITY INDICATING METHOD DEVELOPMENT & VALIDATION OF BILASTINE BY RP-HPLC METHOD},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {7},
        pages = {3529-3537},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=188761},
        abstract = {A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Bilastine in bulk form and marketed formulation. Separation of Bilastine was successfully achieved on a Symmetry C18, 250 mm x 4.6 mm i.d.5µm particle size column in an isocratic mode of separation utilizing Acetonitrile and Water in the ratio of 40:60% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 245nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 6-14mcg/mL for Bilastine. The correlation coefficient was found to be 0.9983 for Bilastine. The LOD and LOQ for Bilastine were found to be 0.05µg/mL and 0.15µg/mL respectively. The proposed method was found to be good percentage recovery for Bilastine, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.},
        keywords = {Bilastine, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.},
        month = {December},
        }

Cite This Article

Mishra, M. C., & Satpathy, P. R., & Shukla, N., & Mishra, J. P. (2025). STABILITY INDICATING METHOD DEVELOPMENT & VALIDATION OF BILASTINE BY RP-HPLC METHOD. International Journal of Innovative Research in Technology (IJIRT), 12(7), 3529–3537.

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