کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1222764 967871 2008 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Investigation of mass-balance issue in e-beam sterilized paclitaxel eluting coronary stents by SPME/GC-MS
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Investigation of mass-balance issue in e-beam sterilized paclitaxel eluting coronary stents by SPME/GC-MS
چکیده انگلیسی
Paclitaxel eluting coronary stents were sterilized by e-beam in a closed system, to investigate sterilization related mass-balance issues and evaluate potential volatile paclitaxel degradation products. A solid-phase microextraction (SPME) method utilizing a polydimethyl-siloxane/divinyl-benzene (PDMS/DVB) fiber was optimized for extracting the volatiles from the head-space of the sterilized stents. GC-MS was used for separation, identification, and quantitation of the components. Benzaldehyde and benzoic acid were identified as paclitaxel related volatile degradation products. Three groups of stents were included in the study, a control group (not exposed to e-beam), a group sterilized at 25 kGy, and a final group sterilized at 75 kGy. The stents sterilized by e-beam at 75 kGy contained significantly higher levels of benzoic acid relative to the controls and the stents at 25 kGy contained intermediate levels of benzoic acid. The benzaldehyde levels increased in the 25 kGy e-beam sterilized stents relative to the control but remained fairly constant in the 75 kGy e-beam sterilized stents relative to the 25 kGy e-beam results. Mechanism for the formation of benzoic acid and benzaldehyde from paclitaxel was proposed. The levels of benzoic acid and benzaldehyde observed on the stents did not resolve the original mass-balance issue, but most likely contribute to the lack of mass balance observed for paclitaxel.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 48, Issue 3, 4 November 2008, Pages 568-572
نویسندگان
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