Analytical Method Development for Related Substances in Pharmaceutically Important Bulk Drugs and Intermediates

Abstract

In pharmaceutical industry, impurity profile is mandatory requirement for drug products. Typically, impurity profile of drugs consisting of both identified and unidentified impurities. Appropriate high performance liquid chromatography (HPLC) and gas chromatography (GC) techniques support for generating an impurity profile and finalised conditions will be standardized to detect all the impurities present in the product. This procedure involves selecting a suitable column, optimizing the mobile phase pH, finalising the flow rate, selecting the type of detector and maintaining column temperature. Once the conditions are optimized for a particular product and its impurity profile will be standardized.