Fast and Straightforward Lipid Quantification in Pharmaceutical Compositions Using NMR.

Liposomes are versatile nanoscale delivery systems used extensively in pharmaceuticals. Accurate quantification of lipids in liposome formulations is critical for ensuring the product quality and efficacy. This study evaluates the use of NMR spectroscopy applied to lipid quantification within liposomes. The investigation focused on lipids commonly found in liposomal products and other lipid-based delivery systems, such as DSPC, DOPC, cholesterol, and DMPE-PEG2K. Lipid quantification was performed using both an internal reference and an external standard through PULCON (pulse length-based concentration determination) methods. Both methods showed high accuracy, precision, and reproducibility. Additionally, the PULCON NMR technique offered enhanced consistency and faster analyses, making it particularly suitable for industrial needs involving rapid analysis across numerous samples. The quantification of liposome solutions was also conducted using a UPLC-ELSD method for a comparison of the two techniques. These findings support the refinement of rapid, accurate lipid quantification methods, essential for quality control in large-scale manufacturing processes and optimizing the drug product formulation process.