Analytical method development is critical in drug development, ensuring the quality, efficacy, and safety of pharmaceuticals. Techniques like High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Mass Spectrometry (MS) are widely used to quantify drug compounds, identify impurities, and ensure product consistency. These methods help streamline the drug approval process by providing accurate and reliable data.
Chromatography, particularly HPLC and Gas Chromatography, plays a pivotal role in the development of analytical methods. These techniques separate complex mixtures into individual components, enabling researchers to identify and quantify drug compounds and impurities. The flexibility and sensitivity of chromatographic methods make them indispensable in pharmaceutical quality control and drug research.
Stability-indicating methods are developed to detect changes in a drug’s chemical composition over time. These methods ensure that pharmaceuticals remain stable and effective throughout their shelf life. By identifying degradation products and impurities, stability studies help in designing robust formulations and determining expiration dates.