Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors: Dr. Meera Kapoor, Mr. Ravi Deshmukh

Abstract: Stability-indicating analytical methods are pivotal in the pharmaceutical industry for evaluating the degradation behavior and shelf-life of drug substances and products. These methods are designed to accurately detect, quantify, and separate the active pharmaceutical ingredient (API) from its degradation products under various stress conditions, including heat, light, humidity, and oxidation. This paper provides an extensive review of current stability-indicating techniques, emphasizing High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), and spectroscopic methods. Method development, validation, and regulatory considerations are discussed, highlighting the importance of robust analytical protocols for quality control and regulatory compliance. The integration of hyphenated techniques and chemometric tools enhances sensitivity, precision, and reproducibility. Implementing stability-indicating analytical methods ensures drug safety, efficacy, and regulatory acceptance, forming the backbone of modern pharmaceutical quality assurance.

Keywords: Stability-Indicating Methods, HPLC, UPLC, Pharmaceutical Analysis, Degradation Products, Drug Stability, Regulatory Compliance