title: Simple and precise detection of lipid compounds present within liposomal formulations using a charged aerosol detector.
abstract: In recent decades the use of liposomal preparations as drug delivery systems has become very attractive in pharmaceutical development. Therefore, thorough characterization and quantification of the lipids which form liposomes is wished from both investigators and regulatory authorities when the application in humans is being considered. In this study a new HPLC method for the detection of lipids in liposomal formulations was established using corona charged aerosol detection (CAD) which has the advantage to be independent of the chemical properties of the analytes. The superiority of this method over UV detection was demonstrated. Compared to UV detection no absorption effects of the organic solvent in the mobile phase interfering with the lipid signals were observed with CAD. CAD showed good linearity (R(2)>0.990) for all liposomal compounds. The acceptance criteria for precision including repeatability were met. The average recovery for each of the excipients of the liposomal formulation was in the range of 90.0-110%.
authors.affiliation: Novartis Pharma AG, Development, Lichtstrasse 35, CH-4058 Basel, Switzerland.
authors.forename: Carina
authors.initials: C
authors.lastname: Schönherr
authors.forename: Sounia
authors.initials: S
authors.lastname: Touchene
authors.forename: Gaston
authors.initials: G
authors.lastname: Wilser
authors.forename: Regine
authors.initials: R
authors.lastname: Peschka-Süss
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Francese
mesh_terms: D000336:Aerosols / Q000737:chemistry; D002784:Cholesterol / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D008055:Lipids / Q000032:analysis*; D008081:Liposomes / Q000737:chemistry*; D010713:Phosphatidylcholines / Q000032:analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D024502:alpha-Tocopherol / Q000032:analysis
chemical_list: D000336:Aerosols; D008055:Lipids; D008081:Liposomes; D010713:Phosphatidylcholines; D002784:Cholesterol; D024502:alpha-Tocopherol