A Comprehensive Review on HPLC Method Development, Validation, Optimization in Pharmaceuticals

Authors: Amjad M* and Sarfraz S

DOI: 10.23880/oajwx-16000188

Volume 6, Issue 3

Abstract

The analytical method development in Pharmaceuticals is most important because it is the regulatory requirements. The determination of Active Ingredients of Pharmaceuticals (API) and Excipients is only possible when the testing method will be validated as per ICH, WHO guidelines or GMP requirements. The development will be reliable when the correct and precise strategy will be followed. Here, the systematic method development technique and validation parameters have been discussed precisely. This comprehensive review will be very helpful for analysts to develop analysis method of new molecules present in any pharmaceutical formulation. The validation concept and various techniques of validation have also been argued to create interest for the researchers.

Keywords: Method; Development; Approach

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