Bioanalytical systems are increasingly becoming crucial in pharmaceutical drug development. From traditional assays such as ELISA to more advanced systems such as MesoScale Cytokine Multiplex assays, analytical laboratories now have multiple alternatives. HPLC systems are one such robust bioanalytical tool.
HPLC stands for high-performance liquid chromatography. So, HPLC systems have multiple applications in pharmaceuticals. It includes a stationary column through which a sample is passed. Under pressure, each component will elute differently and thus have a different flow rate. As a result, individual components will elute at different times and help researchers identify and quantify each sample constituent. The current article discusses various applications of HPLC lab in pharmaceutical quality control for ensuring drug safety and efficacy.
HPLC labs ensure drug Safety
HPLC systems have different individual units. Hence, each application will dictate the factors necessary for HPLC analysis. For example, HPLC has multiple assay methods. Hence, during pharmaceutical regulatory assessments, the equipment and specifications will be determined depending on regulatory guidance.
HPLC is one of the most employed analytical tools in the development and manufacturing of drug products. Moreover, its use is not confined to just one area of drug development. Scientists employ HPLC at numerous critical steps during the entire life cycle of a drug product. During pharmaceutical quality control, drug developers use HPLC systems to characterize the potential drug compound or treatment candidates while ensuring drug manufacturing is safe and consistent. Besides, typical HPLC experiments may assess the hydrophobicity of a drug molecule and help understand the chemical properties of potential biotherapeutics.
Ensuring the consistency of API is one specific application of HPLC systems. HPLC assays can provide quantitative assessments of molecules and help confirm the correct doses of active ingredients. During quality assurance and quality control testing, HPLC assays can determine crucial quality attributes such as content uniformity, strength and concentration, identity and quality of raw materials, and detection and quantification of impurities.
Drug impurities can be detrimental to patients. HPLC systems are often used to detect and identify drug impurities. HPLC labs often combine the technique with highly efficient detection tools such as UV detectors to acquire a comprehensive profile of drug impurities.
Similarly, HPLC assays are crucial in stability studies. Environmental factors, such as light, heat, humidity, and oxygen, can affect the drug formulation over time. HPLC assays can identify degradation products and determine the extent of modification over time. Hence, they are crucial in determining shelf life. For example, some biologic drug products are sensitive and may aggregate over time due to improper storage. HPLC labs can monitor these aggregations.
Although HPLC systems have multiple applications, identifying the method and equipment is critical for specific applications. Pharmaceutical drug development involves numerous regulatory guidance and requirements. Hence, evaluating these guidelines will be necessary to determine the right equipment, method, and experimental specifications. Besides identifying individual experimental parameters such as column and mobile phase properties, instrumental design, column temperature, and injection parameters should also be considered while using HPLC systems.
Conclusion
HPLC assays are hugely crucial in pharmaceutical analysis. Its versatility and accuracy make it an ideal platform for different pharmaceutical and drug development assessments. However, identifying the right factors during method development will be crucial for expanding its applications beyond drug development.