HPLC (High-Performance Liquid Chromatography) is widely used in the pharmaceutical industry because it is accurate, sensitive, and reliable for analyzing drugs and formulations.
Here are the common applications of HPLC in pharmaceuticals:
1. Drug Identification
- Confirms the identity of active pharmaceutical ingredients (APIs) in a formulation.
- Ensures the correct compound is present in tablets, injections, or liquids.
2. Assay of Drug Content
- Determines the amount of active drug in a dosage form.
- Ensures correct dosage and quality control of medicines.
3. Purity Testing
- Detects impurities, degradation products, or contaminants in drugs.
- Helps in monitoring stability and shelf life.
4. Impurity Profiling
- Separates and quantifies related substances or by-products in drug synthesis.
- Ensures regulatory compliance for safety.
5. Stability Studies
- Monitors drug stability under different conditions (temperature, humidity, light).
- Detects degradation products over time.
6. Bioanalysis
- Measures drug concentrations in biological fluids (blood, plasma, urine).
- Useful in pharmacokinetics and therapeutic drug monitoring.
7. Formulation Development
- Assists in optimizing drug formulations and checking uniformity of content.
8. Chiral Separation
- Separates enantiomers of chiral drugs (active vs inactive forms).
- Important because different enantiomers may have different pharmacological effects.
In simple words:
HPLC in pharmaceuticals is used to identify drugs, measure how much is present, check purity, study stability, analyze in the body, and separate drug forms.
It ensures safety, quality, and effectiveness of medicines.