Abstract

A REVIEW ON STABILITY INDICATING HPLC METHOD DEVELOPMENT

Supriya S. Kalel* and Narendra M. Gowekar

ABSTRACT

High-resolution liquid chromatography (HPLC) is one of the most effective procedures for quantitative and qualitative drug product analysis, as well as determining drug product stability. HPLC methods for separating various drug-related contaminants that occur during the synthesis or production of a drug product are used to determine stability. This article examines the tactics and challenges involved in developing a pharmacological substance stability indicating HPLC system. In order to maximise the detection of all possibly significant degradants, a number of crucial chromatographic variables were investigated. The method's capacity to differentiate core medication components from contaminants should be thoroughly tested. Forced degradation studies on new chemical entities and medicinal products are necessary to develop and demonstrate the specificity of such stability indicating methodologies. Practical tips are presented at every level of drug development to assist avoid failures.

Keywords: Forced degradation, HPLC, Stability indicating method.