Quantitative analysis of lipids and nucleic acids in lipid nanoparticles using monolithic column

Lipid nanoparticles, a promising platform for drug delivery, effectively encapsulating and protecting nucleic acids. Comprising cationic or ionizable lipids, helper lipids, and PEGylated lipids, LNPs facilitate cellular uptake and control of payload release. The composition of lipids is crucial for optimizing LNP formulations, necessitating robust analytical methods. This study presents the development of a reverse phase liquid chromatography method to separate and quantify lipids and nucleic acid in LNP formulations. The method utilizes a PATfix^® analytical system equipped with an evaporative light scattering detector and a monolith CIMac™ C4 HLD chromatographic column. The method demonstrated efficient lipid separation and detection, with validation following international chromatography handbook guidelines, highlighting its sensitivity, linearity, precision, and accuracy. Furthermore, the method’s suitability for quantitative analysis was verified by assessing lipid ratios in various LNP formulations, confirming its applicability for monitoring lipid composition throughout the LNPs’ manufacturing process.

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