Pharmaceutical companies need to ensure that their products are safe and work as intended, which is why quality control is so important within the pharmaceutical industry. Through quality control, pharmaceutical companies can verify that drugs are pure, safe, and consistent.
High-performance liquid chromatography (HPLC) plays an essential role in pharmaceutical quality control. If you’re considering a career in the pharmaceutical industry, find out how your HPLC training can be used to keep drugs safe and reliable.
HPLC Plays a Key Role in Verifying Content Uniformity in Pharmaceuticals
Pharmaceutical companies may manufacture millions of individual oral dosage forms (OSDs) of a drug, such as tablets or capsules, and each one must be the same as the next. In particular, the amount of the active pharmaceutical ingredient (API)— the ingredient responsible for the drug’s therapeutic effects—needs to be consistent in every tablet and capsule. Maintaining API consistency is essential to ensuring that patients receive the correct dosage.
This consistency of OSDs is called content uniformity, which is an essential step in the quality control of pharmaceuticals. Your HPLC certification can be put to use here, since HPLC is one of the most common methods for testing content uniformity. For example, samples of OSDs may be taken from different batches and tested using HPLC. The HPLC results will show the amount of API in each individual OSD, thus enabling analysts to verify whether or not API is consistent across batches.
HPLC Can Help Detect Impurities So That Pharmaceuticals Are Safe to Use
Impurities in pharmaceutical drugs can pose a threat to the safety of patients. Such impurities may cause negative reactions in patients, or they may compromise the effectiveness of the drug’s API. For those reasons, testing for impurities is essential in pharmaceutical quality control and it’s a step in which HPLC plays a major role.
HPLC separates the constituent parts of a mixture, such as a drug, allowing analysts to verify what those parts of the mixture are. As a result, pharmaceutical companies use HPLC to determine if a drug contains substances that should not be there. With this data, drug manufacturers can find ways to remove the impurities so that the drugs that will eventually be given to patients perform as intended.
Use Your HPLC Certification to Analyze Drug Stability and Degradation
Another important quality control aspect in the pharmaceutical industry is called drug stability. Just like food, pharmaceutical drugs tend to degrade over time. Storage conditions, such as whether the drug is exposed to oxygen or sunlight, or it is kept in dry or humid conditions, can also affect the rate at which a drug degrades. This rate of degradation is referred to as drug stability. Degradation can change the amount, stability, and potency of the API, thus compromising the effectiveness of the drug itself.
To analyze drug stability, it’s important to test the drug at various stages of its lifecycle and in different conditions. HPLC is a powerful pharmaceutical technology that is often used in drug stability tests. Analysts can find out the level of API in a drug kept in different storage conditions and at different points in time. With this data, the manufacturer can develop shelf-life and storage guidelines to ensure the quality of the final product.
Are you interested in a career in the pharmaceutical industry?
Contact Toronto Institute of Pharmaceutical Technology to learn more about our HPLC program.