Pharmaceutical Analysis

Chromatography and Mass Spectrometry are extensively used in the drug development stage of generic products. The ICH Q3B guidelines address the reporting threshold, identification threshold, and threshold for impurities in the product.  Chromatography (LC) and Gas Chromatography (GC) are extensively used to analyze stable compounds. Labile compounds require derivatization prior to Liquid Chromatography or Gas Chromatography analysis. For certain analyses, Liquid Chromatography- Ultraviolet Detection (LC-UVD) and Gas Chromatography-Flame Ionization Detection (GC-FID) techniques may be deemed suitable. However, Liquid Chromatography-Mass Spectrometry (LC-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) are techniques of choice when higher specificity and sensitivity are required. Gas Chromatography-Electron Capture Detection (GC-ECD) techniques are commonly used for halogenated PGIs/GIs to enhance sensitivity and selectivity. Some spectroscopic techniques like Nuclear Magnetic Resonance (NMR), light scattering, and Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) are used in analyzing PGIs/GIs.