ANALYTICAL HYPHENATION: A NOVEL APPROACH TO PHARMACEUTICAL STABILITY TESTING

Palivela Kumari, Dr. Kuna Mangamma*, Kolli Devi Varaha Satya Kumari, Bollipalli Sanath, Golla Richa Durga Bhavani

ABSTRACT

The pharmaceutical industry is growing quickly, especially with fixed-dose combination (FDC) formulations. This leads to a greater variety of contaminants and degradation products because of different APIs, processing techniques, and storage conditions. Chronic illnesses like diabetes and hypertension necessitate long-term medicine intake, which may result in cumulative exposure to cytotoxic or genotoxic chemicals, even if regulatory agencies enforce impurity limits (usually within 1%). Therefore, it is crucial to thoroughly identify and characterize these contaminants. For the purpose of assessing the best storage and labeling practices and guaranteeing the safety and effectiveness of drugs, stability testing. which includes forced degradation techniques including hydrolysis, oxidation, acidic, alkaline, and thermal stress is essential. Sophisticated hyphenated approaches have proven indispensable in addressing the analytical issues presented by impurity profiling. Both qualitative and quantitative impurity analysis have been transformed by the combination of spectroscopic detection and chromatographic separation. Pharmaceutical research frequently uses techniques like LC/MS, LC/NMR, LC/NMR/MS, GC/MS, and LC/MS/MS because of their sensitivity and ability to clarify structures. These techniques provide quick and precise impurity profiling, facilitating safety assessment in drug development and conforming to changing regulatory requirements. The current conventional and hyphenated analytical methods for identifying drug degradation products are described in detail in this thorough study. In order to demonstrate the advancements in impurity analysis that support pharmaceutical quality, efficacy, and safety, we look at forced-degradation approaches in addition to newly developed hyphenated procedures.

Keywords: Liquid Chromatography (LC); Mass Spectroscopy (MS); Hyphenated Techniques; Force Degradation.