What are the applications of High Performance Liquid Chromatography in drug quality control?
High Performance Liquid Chromatography (HPLC) is widely used in pharmaceutical quality control. Below are some common applications of HPLC in pharmaceutical quality control:
1. Drug Purity Analysis:
HPLC can be used to determine the purity of a drug, i.e., the content of active ingredients in the drug. By injecting the drug sample into the HPLC system, the different retention times and separation of components on the stationary phase can be used for quantitative analysis of each component in the drug. This is crucial for ensuring the quality and safety of drugs.
2. Impurity Analysis:
Various impurities, such as organic impurities, inorganic impurities, and impurity-related substances, may be present in drugs. HPLC can separate and detect these impurities, helping to determine the purity and safety of drugs. By comparing the relative peak areas of the impurity peaks and the pure drug peaks in the sample, the content of impurities can be calculated.
3. Drug Degradation Product Analysis:
Drugs may decompose during storage and use, producing some unstable degradation products. HPLC can separate and detect these degradation products, helping to determine the stability and shelf life of drugs. By comparing the relative peak areas of degradation product peaks and original drug peaks in the sample, the content of degradation products can be calculated.
4. Drug Dissolution Testing:
Drug dissolution refers to the amount of drug released from a solid dosage form within a certain period. HPLC can be used to determine the dissolution rate of drugs to evaluate their release rate and dissolution characteristics. By dissolving the drug formulation and analyzing it through the HPLC system, dissolution curves at different time points can be determined.
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