Review Article | Volume : 1 Issue : 3, May 2011

Development and validation of dissolution procedures

Bhavesh Vaghela Rajan Kayastha Nayana Bhatt Nimish Pathak Dashrath Rathod   

Open Access   

Abstract

Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot to lot quality of drug product. The development and validation of dissolution procedures is of paramount importance during development of new formulation and in quality control. The issolution procedure must be properly developed and validated. The objective of this paper is to review the development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, limit of detection, limit of quantitation and robustness of methods. Developing and validating dissolution test procedures can be a challenging process, on multiple fronts. Methods must be developed and validated not just for the dissolution test procedure itself, but also for any assay used to evaluate the test results.


Keyword:     Dissolution procedure development Dissolution apparatus Dissolution medium Validation parameters Quality control.


Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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