Standard Test Method for Lipid Quantitation in Liposomal Formulations Using High Performance Liquid Chromatography (HPLC) with a Charged Aerosol Detector (CAD)

Importancia y uso:

5.1 The growing interest in liposomal formulations in the pharmaceutical industry requires QC and thorough characterization and quantification of lipids that form liposomes (6). Lipid composition has proven to be a critical attribute of the liposomal formulation; it directly influences the stability of the formulation, drug loading, performance, size, and surface characteristics of the liposome. Cholesterol plays a key role in controlled drug release by adding stability to the liposome (7). Significant variation in the lipid composition and ratio of the components will influence the safety, biodistribution, drug efficacy, and drug release kinetics of the liposomal formulation (8-11).

5.2 This test method is a fast and reliable procedure for the quantification of cholesterol, DSPE-PEG 2000, and HSPC in liposomal formulations using HPLC-CAD.

5.3 This test method can be used for QC and QA and to ascertain variations in component profiling of liposomal formulations.

Subcomité:

E56.08

Referida por:

E3409-24

Volúmen:

14.02

Número ICS:

07.120 (Nanotechnologies)

Palabras clave:

CAD; cholesterol; DSPE-PEG 2000; HPLC; HSPC; lipid quantitation; liposomal formulation;