ADVANCES IN STABILITY-INDICATING RP-HPLC METHODS FOR FIXED-DOSE ANTI-MALARIAL COMBINATIONS: A COMPREHENSIVE REVIEW
Sarvepalli Gnana Samanvitha, Shweta Purohit Nayak*, Shaik Naziya Fathima, MD. Saniya, Mallani Sirisha, Arunabha Mallik
ABSTRACT
Fixed-dose combinations (FDCs) of anti-malarial drugs play a crucial role in global malaria control by improving therapeutic efficacy, enhancing patient compliance, and minimizing resistance development. As these products often contain chemically diverse actives such as artemisinin derivatives, Lumefantrine, Amodiaquine, Mefloquine, Piperaquine, and Sulfadoxine-Pyrimethamine robust stability-indicating analytical methods are essential to ensure safety, efficacy, and regulatory compliance. Reversed-phase high-performance liquid chromatography (RP-HPLC) remains the most widely adopted analytical platform for stability studies due to its high resolution, reproducibility, selectivity, and compatibility with a broad range of pharmaceutical matrices. This comprehensive review summarizes the recent advances in stability-indicating RP-HPLC method development for anti-malarial FDCs, focusing on chromatographic conditions, forced degradation studies, validation parameters, green analytical initiatives, and Quality by Design (QbD) strategies. Current trends emphasize eco-friendly solvents, miniaturized sample preparation, novel stationary phases, and regulatory alignment with ICH Q1A (R2) and Q2 (R2). Critical challenges and future prospects for analytical improvement in anti-malarial quality control are highlighted.
Keywords: Stability-indicating RP-HPLC, Anti-Malarial Fixed-Dose Combinations, Artemether and Lumefantrine, Artesunate and Amodiaquine.
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