High performance liquid chromatography with evaporative light scattering detection for the characterisation of a vesicular delivery system during stability studies

A normal phase high performance liquid chromatography method with evaporative light scattering detection was developed for the simultaneous quantification of the lipid constituents of a non-ionic surfactant vesicle (NIV) delivery system consisting of tetra-ethylene glycol mono n-hexadecyl ether, cholesterol and dicetyl phosphate. An accelerated stability study performed at 25 °C/60% relative humidity (RH) and 40 °C/75% RH indicated that the NIV were chemically stable. Similar results were observed when stored at 4 °C for 469 days. This chromatographic method developed is a sensitive, robust and high throughput analytical technique that offers the potential for rapid quantification of lipids in liposomal and vesicular systems. The results of the chromatographic studies were supported by parallel size and zeta potential measurements.