Bioanalytical method development and validation

Authors

  • A. S. Welankiwar Government College of Pharmacy Amravati, MS
  • Manoj S. Charde Government College of Pharmacy, Kathora Naka, Amrawati-444604 Maharashtra
  • Jitendra Kumar Government College of Pharmacy Amravati, MS
  • R. D. Chakole Government College of Pharmacy Amravati, MS

DOI:

https://doi.org/10.7439/ijapa.v3i4.63

Keywords:

External branch of superior laryngeal nerve, thyroidectomy, Hemithyroidectomy

Abstract

Bioanalytical methods are used for the quantitative analysis of drugs and their metabolites in the biological media like saliva, urine, plasma, serum. Development and validation of bioanalytical method is important to understand the pharmacokinetics of any drug and/or its metabolites. Bioanalytical method development consists of three essential interrelated parts sample preparation, chromatographic separation and detection by using proper analytical method. Validation of a Bioanalytical method is the process by which it is established that the performance characteristics of the method meet the requirements for the intended Bioanalytical application. The validation is further divided into 3 segments full validation, partial validation, and cross validation each of which has its own purpose. This review describes mainly the various aspects for development of bioanalytical method and for the validation of bioanalytical methods. Also the Bioanalytical method transfer is also described.

Downloads

Download data is not yet available.

Author Biography

  • Manoj S. Charde, Government College of Pharmacy, Kathora Naka, Amrawati-444604 Maharashtra
    Assitant Professor

Downloads

Published

2014-01-01

Issue

Vol. 3 No. 4 (2013): Oct-Dec

Section

Review Article

License

Authors who publish with this journal agree to the following terms:

a) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.

b)Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.

c) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).

After acceptance of the article, the author has to submit copyright form signed by all authors.

How to Cite

1.
Bioanalytical method development and validation. Int J of Adv in Phar Ana [Internet]. 2014 Jan. 1 [cited 2026 Jan. 3];3(4):90-4. Available from: https://ssjournals.co.in/index.php/ijapa/article/view/1376
Crossref
Scopus
Google Scholar
Europe PMC