Drug Discovery and Development
- Impurity Profiling: GC and LC are employed to identify and quantify impurities present in drug substances and formulations. This helps ensure the purity and safety of the final product.
- Stability Studies: These techniques are used to monitor the degradation of drugs over time under different conditions. This information is essential for determining shelf life and storage conditions.
- Method Development: GC and LC are used to develop analytical methods for the quantification of drug substances and their related compounds. These methods are then used in quality control and release testing.
Quality Control and Release Testing
- Assay: GC and LC are used to determine the accurate concentration of the active pharmaceutical ingredient (API) in drug formulations.
- Related Substances: These techniques are used to identify and quantify potential impurities and degradation products in drug substances and formulations.
- Dissolution Testing: LC is used to measure the rate and extent of drug release from solid dosage forms, such as tablets and capsules.
Instruments
High/Ultra performance liquid chromatography HPLC/UPLC
- Detection: UV-VIS, Diode array detector (DAD), Light scattering detector (ELSD), Charged aerosol detector (CAD), Refractive index detector (RI detector), Fluorescence detector (FLD)
Ion chromatography IC
- Conductivity detection: anions/cations
Gas chromatography GC
- Sampler: liquid, headspace
- Flame ionization detection (FID)
