A Review on Development of Stability Indicating Analytical Methods for drugs in Bulk and Pharmaceutical Dosage Form

Abstract

High performance liquid chromatography (HPLC) is an important analytical tool in analyzing drug stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants. Forced degradation studies (chemical and physical stress testing) of new chemical entities and drug products are essential to help develop and demonstrate the specificity of such stability-indicating methods. In addition to demonstrating specificity, forced degradation studies can be used to determine the degradation pathways and degradation products of the APIs that could form during storage, and facilitate formulation development, manufacturing, and packaging. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc. ICH Q1A, QIB and Q2B exemplify the forced degradation studies. This review overviews the approaches and trends that are used in forced degradation studies.