A Review of HPLC Method Development and Validation as per ICH Guidelines

Abstract

Method development and validation are continuous processes that progress in parallel with the evolution of drug products. Changes encountered during drug development may require modifications to existing analytical methods. These modifications to the methods, in turn, may require additional validation. The advent of new techniques and improved instrumentation in the field of analysis may give way to more sensitive, precise, and accurate methods if the existing methods are erratic or unreliable; time-consuming, or too expensive. Thus, continuous new analytical method development and validation activities are essential for the growing drug development programs.

New Enhancement Spectrofluorimetric Determination of Anti‐Breast Cancer Drugs Palbociclib by Biogenic‐Synthesized Alumina/NiO Nanocomposite

“…The validation was carried out to ensure the applicability of the suggested methodology with respect to precision and accuracy for the quantification of the analyte under analysis. The validated FI system for identifying PAL was developed in compliance with the ICH recommendations [49] . The calibration graph of the established spectrofluorometric device for PAL assessment was constructed using FI vs. the concentrations of analyte (Figures 10a and 10b).…”