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

Development and validation of a novel UPLC-ELSD method for the assessment of lipid composition of nanomedicine formulation

“…To make sure that this analytical method could be applied for daily quality control along a manufacturing process, when consistent precisions is required, intra-and inter-day precisions were evaluated directly on a single nanoparticle suspension. The results obtained in these studies are presented in [22,41,54,85]. As part of the quantification process, repeatability and intermediate precision of the freeze-dried process were 0.37% and 0.52%, respectively.…”

“…Table 4, the repeatability of all analytes ranged from 0.9% to 5.3% and the accuracy from 83.5% to 112.2%. For lipid analysis repeatability, a value lower than 5% is generally accepted [22,41,54,85].…”

“…This detection technique was chosen in these studies for several reasons. First, this equipment is well established in the quality control of liposome suspensions [53,54]. Second, contrary to UV and refractive index (RI) detection, solvent selection and gradient elution are not limiting factors [55,56].…”