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

Varache, M ORCID: https://orcid.org/0000-0001-7166-2253, Ciancone, M and Couffin, A-C 2019. Development and validation of a novel UPLC-ELSD method for the assessment of lipid composition of nanomedicine formulation. International Journal of Pharmaceutics 556 , pp. 11-23. 10.1016/j.ijpharm.2019.05.038

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Abstract

Lipid nanocarriers incorporating glycerides, polyethylene glycol (PEG)-stearates and phospholipids have attracted great attention for in vivo diagnostic, in vivo imaging, activated or non-activated targeted drug delivery. For quality control purposes, the development of appropriate methods for the quantification of their lipid components is needed. In the present study, we developed an analytical method for lipid quantification in formulated nanoparticles. PEG-stearates and glycerides were analyzed in a single run by RP-UPLC-ELSD using a two-step gradient elution program, while the analysis of phospholipids was accomplished by HILIC-UPLC-ELSD after isolation using an SPE silica column. Using both isolated compounds and commercial lipid standards, calibration curves were produced using second-order polynomials to attain the quantitative evaluation of each lipid excipient. Relative standard deviation of all analytes was between 0.9% and 5.3% for intra-day precision and recovery ranged from 83.5% to 112.2%. The presented method was successfully implemented to study the manufacturing process and stability of the formulated lipid excipients during long-term storage and accelerated conditions. The formulation lipid yield was determined and found equal to 82.5%.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Dentistry
Publisher:	Elsevier
ISSN:	0378-5173
Date of First Compliant Deposit:	9 July 2019
Date of Acceptance:	13 May 2019
Last Modified:	06 Nov 2024 20:45
URI:	https://orca.cardiff.ac.uk/id/eprint/124096

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