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Lipid Nanoparticle Characterization by RP-HPLC-CAD on a C6-Phenyl Column
Lipid nanoparticles (LNPs) are essential carriers for gene therapies, including mRNA vaccines, composed of cholesterol, helper lipids, ionizable lipids, and PEGylated lipids. Accurate quantification and identification of these components are critical for product quality. This study presents a 20-minute reversed-phase UHPLC method with charged aerosol detection (RP-UHPLC-CAD) using a Gemini C6 Phenyl column to enhance chromatographic efficiency. Lipid standards and LNP samples were prepared in anhydrous ethanol and analyzed following demulsification and centrifugation. The method achieved clear resolution of SM-102, cholesterol, DSPC, and DMG-PEG 2000, with high reproducibility (RT %RSD < 0.5%) and strong linearity (R^2 > 0.9999) for most analytes. This approach demonstrates potential for routine quality control of LNP formulations.
Lipid Nanoparticle Characterization by RP-HPLC-CAD on a C6-Phenyl Column
Lipid nanoparticles (LNPs) are essential carriers for gene therapies, including mRNA vaccines, composed of cholesterol, helper lipids, ionizable lipids, and PEGylated lipids. Accurate quantification and identification of these components are critical for product quality. This study presents a 20-minute reversed-phase UHPLC method with charged aerosol detection (RP-UHPLC-CAD) using a Gemini C6 Phenyl column to enhance chromatographic efficiency. Lipid standards and LNP samples were prepared in anhydrous ethanol and analyzed following demulsification and centrifugation. The method achieved clear resolution of SM-102, cholesterol, DSPC, and DMG-PEG 2000, with high reproducibility (RT %RSD < 0.5%) and strong linearity (R^2 > 0.9999) for most analytes. This approach demonstrates potential for routine quality control of LNP formulations.
Lipid Nanoparticle Characterization by RP-HPLC-CAD on a C6-Phenyl Column
Lipid nanoparticles (LNPs) are essential carriers for gene therapies, including mRNA vaccines, composed of cholesterol, helper lipids, ionizable lipids, and PEGylated lipids. Accurate quantification and identification of these components are critical for product quality. This study presents a 20-minute reversed-phase UHPLC method with charged aerosol detection (RP-UHPLC-CAD) using a Gemini C6 Phenyl column to enhance chromatographic efficiency. Lipid standards and LNP samples were prepared in anhydrous ethanol and analyzed following demulsification and centrifugation. The method achieved clear resolution of SM-102, cholesterol, DSPC, and DMG-PEG 2000, with high reproducibility (RT %RSD < 0.5%) and strong linearity (R^2 > 0.9999) for most analytes. This approach demonstrates potential for routine quality control of LNP formulations.