Making Analytical Method Improvements to Fatty Acid Analysis
Challenge: The goal of this project was to develop efficient analytical methods for complete compositional analysis of lipid-based drug candidates. Analytical method requirements included extraction, separation, identification and quantification. Such work would support development of formulations which would include a small amount of a well accepted non-medicinal ingredient commonly used in food and drug products. This undertaking focused on the development of a full fatty acid profile analysis of new lipid-based drug candidates targeted to formulate advanced products related to High Density Lipoprotein (HDL), often called "good cholesterol".
Solution: For companies developing products related to HDL, its drug candidates relate to the various roles of HDL as a transport vehicle, including removing excess cholesterol from the body, delivering molecules to cells and removing unwanted materials from the body. Therefore, having analytical methods capable of defining the composition of potential drug candidates is an essential step to achieving desirable product formulations. These analytical methods were not available in the published literature.
Result: Achievements highlighted in this work include:
- Developed the optimal extraction and following derivatization procedures of fatty acids and phytosterols from the proposed lipid materials;
- Developed two capillary GC and one head space (organic volatile impurity) methods for qualitative and quantitative analysis (more that 30 different) fatty acids and phytosterols in the materials;
- Developed a quantitative Atomic Absorption (AA) analytical method for the monitoring the calcium and sodium levels in the products;
- Developed specific testing procedures (water and heavy metals contents) suitable for monitoring the quality of the products.