📄 Abstract
Stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) methods are indispensable in pharmaceutical development, regulatory submissions, and quality control. These methods ensure accurate quantification of active pharmaceutical ingredients (APIs) in the presence of degradation products, process impurities, and formulation excipients. Recent years (20202025) have witnessed considerable advancements in chromatographic selectivity optimization, forced degradation design, impurity profiling, analytical Quality by Design (AQbD), and environmentally sustainable analytical practices. This review critically evaluates contemporary strategies in stability-indicating RP-HPLC method development, validation under ICH Q2 (R1/R2), degradation pathway assessment, regulatory expectations, and emerging trends including lifecycle management and green analytical chemistry. Emphasis is placed on practical implementation challenges and industry-oriented best practices.
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📚 How to Cite:
Divya Shivanath Deshmukh, Sachin Bhalekar, Omkar Rajaram Gosavi, Komal Naresh Aher, Ganesh Lamkhade, Kuldeep Ramteke , STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION: CONTEMPORARY ANALYTICAL STRATEGIES, REGULATORY EVOLUTION, AND RECENT ADVANCES , Volume 12 , Issue 5, May 2026, EPRA International Journal of Multidisciplinary Research (IJMR) , DOI: https://doi.org/10.36713/epra27370