Revolutionizing Stability-Indicating Analysis: Advanced RP-HPLC Strategies for Pharmaceutical Excellence

Stability-indicating analysis is vital to pharmaceutical quality control for establishing the safety, efficacy, and quality of pharmaceutical drug products until their expiration date. Reversed-phase high-performance liquid chromatography (RP-HPLC) has recently become an important tool in stability testing because of its high selectivity, sensitivity, and robustness. Abstract/Short: This review focused on recent developments in RP-HPLC approaches for stability-indicating analysis to emphasize their importance in pharmaceutical excellency. Abstract The principles of stability-indicating analysis along with regulatory guidelines, classification of degradation pathways of drugs, and importance of these studies in drug development are discussed. This review outlines the main advantages of RP-HPLC in stability testing, which include selective separation, high sensitivity and excellent ruggedness. In addition, we covered the challenges of stability testing and provided a solution and response with RP-HPLC through optimized separation and sensitive detection and validation of the methods described. The development of recent RP-HPLC columns, including sub-2 μm packing materials for higher-resolution applications and stationary phases with specific interaction sites for improved selectivity, has greatly expanded the separation space and analytical flexibility. The results indicate that advances in detection methods, specifically mass spectrometry, along with new strategies like smartphone-based fluorescence detection, provide further specificity and sensitivity for stability-indicating analysis. Method validation according to the ICH and USP guidelines is important, as illustrated by case studies: development and validation of stability-indicating RP-HPLC methods for the estimation of betamethasone acetate and betamethasone dipropionate simultaneously; design and validation of a stability-indicating RP-HPLC method for estimated estimation of calycosin-7-glucoside in Corydalis species; analysis of coexisting standard products and stability studies; and HPLC separation of flufenamic acid and its impurities by a rapid method validated in an effective selection of experimental conditions. Lastly are the applications of RP–HPLC in stability studies in terms of pharmaceutical product, degradation product and regulatory compliance approaches. This review wraps up by recapping the major developments in RP-HPLC for stability-indicating analysis and what it means for continuous improvements in pharmaceutical quality and some trends and future prospects PHPLC in these regards.