Development and Validation of a New RP- HPLC Method for the Zilucoplan in Pharmaceutical Dosage form as Per ICH Guidelines

Authors

  • N. Keerthi Reddy Department of Pharmaceutical Analysis, Nirmala College of Pharmacy, Kadapa Dist., Andhra Pradesh Author
  • N.V. Murali Krishna Department of Pharmaceutical Analysis, Nirmala College of Pharmacy, Kadapa Dist., Andhra Pradesh Author
  • U. Mohan Kumar Department of Pharmaceutical Analysis, Nirmala College of Pharmacy, Kadapa Dist., Andhra Pradesh Author
  • I. Theja Department of Pharmaceutical Analysis, Nirmala College of Pharmacy, Kadapa Dist., Andhra Pradesh Author
  • S. Lakshmi Naga Aparna Department of Pharmaceutical Analysis, Nirmala College of Pharmacy, Kadapa Dist., Andhra Pradesh Author
  • P. Jyothi Department of Pharmaceutical Analysis, Nirmala College of Pharmacy, Kadapa Dist., Andhra Pradesh Author

DOI:

https://doi.org/10.30904/

Keywords:

zilucoplan, validation, reliability, RP-HPLC, ICH guidelines

Abstract

The validation and reliability of a newly developed RP-HPLC method for quantifying zilucoplan in its pharmaceutical form, adhering to ICH guidelines. The method demonstrates specificity, accuracy, precision, and linearity within defined parameters. Robustness was confirmed through stress tests, ensuring suitability for routine quality control. Validation parameters, including system suitability, method precision, and stability testing, meet ICH criteria. Thus, this RP-HPLC method is a dependable tool for assessing zilucoplan quality, bolstering patient safety and drug efficacy assurance.

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Published

2024-05-09

Issue

Vol. 12 No. 01 (2024): IJCPS

Section

Articles

License

Copyright (c) 2024 Author

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

How to Cite

N, K. R., N.V, M. K., U, M. K., I, T., S, L. N. A., & P, J. (2024). Development and Validation of a New RP- HPLC Method for the Zilucoplan in Pharmaceutical Dosage form as Per ICH Guidelines. International Journal of Chemistry and Pharmaceutical Sciences, 12(01), 12-19. https://doi.org/10.30904/