BIOANALYTICAL METHOD VALIDATION- A REVIEW

  • Unique Paper ID: 161339
  • Volume: 10
  • Issue: 3
  • PageNo: 445-455
  • Abstract:
  • Bioanalytical method development is the process of preparing a procedure to know a compound of interest to be identified and quantified in a biological matrix. A compound can be examined by several methods and the choice of analytical method involves many considerations. Analysis of drugs and their metabolites in a biological matrix is carried out using different extraction techniques like liquid-liquid extraction, solid phase extraction (SPE) and protein precipitation. These methods and choice of analytical method describes the process of method development and includes sampling, sample preparation, separation, detection and evaluation of the results. The developed process is then validated. These bioanalytical validations play a pivotal role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies and different parameters like accuracy, precision, selectivity, sensitivity, reproducibility, and stability are performed.

Copyright & License

Copyright © 2025 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{161339,
        author = {Dr Vamseekrishna G and Salman Khan and Paidipamula Tarun kumar and Podila Sai Teja and Sarnala Mahendra and Vankayala Vasu and S V Kali Dinesh and Dr I V Rama Rao},
        title = {BIOANALYTICAL METHOD VALIDATION- A REVIEW},
        journal = {International Journal of Innovative Research in Technology},
        year = {},
        volume = {10},
        number = {3},
        pages = {445-455},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=161339},
        abstract = {Bioanalytical method development is the process of preparing a procedure to know a compound of interest to be identified and quantified in a biological matrix. A compound can be examined by several methods and the choice of analytical method involves many considerations. Analysis of drugs and their metabolites in a biological matrix is carried out using different extraction techniques like liquid-liquid extraction, solid phase extraction (SPE) and protein precipitation. These methods and choice of analytical method describes the process of method development and includes sampling, sample preparation, separation, detection and evaluation of the results. The developed process is then validated. These bioanalytical validations play a pivotal role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies and different parameters like accuracy, precision, selectivity, sensitivity, reproducibility, and stability are performed.},
        keywords = {Bioanalytical method validation , Biological matrix, Bioavailability, Bioequivalence},
        month = {},
        }

Cite This Article

  • ISSN: 2349-6002
  • Volume: 10
  • Issue: 3
  • PageNo: 445-455

BIOANALYTICAL METHOD VALIDATION- A REVIEW

Related Articles