METHOD DEVELOPMENT AND VALIDATION OF HPLC AS PER ICH GUIDELINES - A REVIEW

ABSTRACT

Today, a wide range of industries, including the pharmaceutical, biotechnology, environmental, polymer, and food sectors, use high-performance liquid chromatography (HPLC) for separations and purifications. A little amount of liquid sample is injected into a moving stream of liquid (referred to as the mobile phase) that travels through a column filled with stationary phase particles to get the desired result. Different levels of retention of each component determine how a mixture separates into its constituent parts. An analytical method called high performance liquid chromatography (HPLC) is effective at separating, identifying, and quantifying a wide range of pharmaceuticals and their metabolites. Additionally, it is used to distinguish manufactured medications from contaminants associated with drugs. During the time of separation, to identify and measure the synthetic drug and to minimize additional contaminants. This review provides details on the several phases that go into developing and validating an HPLC technique. The ICH Guidelines for HPLC method validation address every aspect of performance characteristic related to validation, including robustness, range and limit of quantification, specificity, linearity, accuracy, precision, and linearity, as well as testing the suitability of the system.

Keywords: HPLC, ICH, Method Development and Validation.