title: Effects of E-BEAM sterilization on drug-eluting stents: paclitaxel degradation elucidated by LC-MS-MS with information-dependent acquisition.
abstract: Effects of sterilization by electron beam (E-BEAM) on paclitaxel (1) mixed with poly(DL-lactide-co-glycolide) (PLG) in reservoirs of COSTAR Stents are examined by using liquid chromatography-mass spectrometry (LC-MS-MS) techniques with information-dependent acquisition (IDA). Numerous degradation products of 1 are formed in a β-radiation dose-dependent manner to give plethora of low-level degradants. This behavior, together with multiple interferences from PLG-related compounds, creates considerable challenges for analysis of the drug/PLG mixtures. IDA methods with different survey scans are proven to be very efficient in elucidating degradation pathways and in identifying numerous products. Combined LC-MS-MS results from analysis of sterilized drug substance and stents indicate that water addition and oxidative processes together with the isomerization are largely responsible for degradation of 1 under E-BEAM sterilization conditions used.
authors.affiliation: Cordis Corporation, Spring House, PA 19477, USA. iilitche@its.jnj.com
authors.forename: Yuri V
authors.initials: YV
authors.lastname: Il'ichev
authors.forename: Lori
authors.initials: L
authors.lastname: Alquier
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D054855:Drug-Eluting Stents; D004583:Electrons; D010084:Oxidation-Reduction; D017239:Paclitaxel / Q000008:administration & dosage / Q000737:chemistry* / Q000528:radiation effects; D013242:Sterilization / Q000379:methods*; D053719:Tandem Mass Spectrometry / Q000379:methods*; D014867:Water
chemical_list: D014867:Water; D017239:Paclitaxel