title: Development of complementary HPLC-DAD/APCI MS methods for chemical characterization of pharmaceutical packaging materials.
abstract: The chemical characterization of plastics for pharmaceutical packaging has been subject to ever increasing regulatory scrutiny, the reasons for which being: a) plastic additives and degradation products can be extremely hazardous to the patients' health (especially patients on chronic therapy) and b) they offer no therapeutic or formulatory benefit whatsoever. The last decade has seen the issuing of several books, monographs and guidelines dealing with extractables and leachables, however the amount of scientific work done so far is still fairly small (the majority of it performed by only a few research groups), with only a small number of methods published in the literature. This work focuses on developing a set of two complementary HPLC-DAD/APCI MS methods for simultaneous separation, detection, identification and quantification of a wide variety of packaging additives and degradants, the second method specifically targeting a group of compounds known as polymeric hindered amine light stabilizers (HALS), which are known to be notoriously difficult to separate and analyze with standard analytical techniques. The methods are capable of detecting plastic additives present in low ppb concentrations, from samples extracted in solvents with various polarities and pH values. Both methods were developed and optimized using system suitability mixtures comprised of 9 additives commonly encountered in plastic materials, and their practical applicability tested on a variety of extracts from low-density polyethylene (LDPE) and polypropylene (PP), where several additives were successfully separated, detected and identified.
authors.affiliation: Research & Development Institute, ALKALOID AD-Skopje, Blvd. A. Makedonski 12, 1000 Skopje, Macedonia. Electronic address: vpetrusevski@alkaloid.com.mk.
authors.forename: V
authors.initials: V
authors.lastname: Petruševski
authors.affiliation: Faculty of Pharmacy, University of "Ss. Cyril and Methodius", Majka Tereza 47, 1000 Skopje, Macedonia.
authors.forename: S T
authors.initials: ST
authors.lastname: Jolevska
authors.affiliation: Faculty of Pharmacy, University of "Ss. Cyril and Methodius", Majka Tereza 47, 1000 Skopje, Macedonia.
authors.forename: J T
authors.initials: JT
authors.lastname: Ribarska
authors.affiliation: Research & Development Institute, ALKALOID AD-Skopje, Blvd. A. Makedonski 12, 1000 Skopje, Macedonia.
authors.forename: M
authors.initials: M
authors.lastname: Chachorovska
authors.affiliation: Research & Development Institute, ALKALOID AD-Skopje, Blvd. A. Makedonski 12, 1000 Skopje, Macedonia.
authors.forename: A
authors.initials: A
authors.lastname: Petkovska
authors.affiliation: Research & Development Institute, ALKALOID AD-Skopje, Blvd. A. Makedonski 12, 1000 Skopje, Macedonia.
authors.forename: S
authors.initials: S
authors.lastname: Ugarković
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004349:Drug Packaging; D013058:Mass Spectrometry / Q000379:methods*; D004364:Pharmaceutical Preparations
chemical_list: D004364:Pharmaceutical Preparations
keywords: Chimassorb 944; HPLC DAD APCI MS; High pH mobile phase; Plastic additives; Polymeric HALS; Triazine structure