METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC METHOD

B pharmacy

This review focuses on the development and validation of stability-indicating analytical methods (SIAMs) using High-Performance Liquid Chromatography (HPLC), a key tool in pharmaceutical quality control. Stability-indicating methods are essential for monitoring the stability of active pharmaceutical ingredients (APIs) and detecting degradation products under stressed conditions, such as light, heat, humidity, and pH fluctuations. The methodology involves forced degradation studies to identify degradation pathways and optimize chromatographic conditions, including mobile phase composition, column type, and flow rate, to ensure efficient separation of APIs from their degradation products. The validation of these methods, based on regulatory guidelines from the International Council for Harmonisation (ICH) and the U.S. Food and Drug Administration (FDA), ensures accuracy, precision, specificity, linearity, and detection limits. These parameters are critical for confirming that the analytical methods provide reliable, reproducible results suitable for pharmaceutical stability testing. This review also highlights the increasing importance of advanced techniques such as Ultra-High Performance Liquid Chromatography (UHPLC) and mass spectrometry (MS) to enhance sensitivity and detection capabilities.

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