Unit:
Κατεύθυνση Χημική Ανάλυση-Έλεγχος ΠοιότηταςLibrary of the School of Science
Author:
Konstantinou Christina
Supervisors info:
Μιχαήλ Κουππάρης, Καθηγητής, Τμήμα Χημείας, ΕΚΠΑ
Original Title:
Ανάπτυξη και επικύρωση μεθόδου για μελέτη μετανάστευσης ουσιών από περιέκτη φαρμακευτικού σκευάσματος βορικοναζόλης με Υγροχρωματογραφία συζευγμένη με Φασματομετρία Μαζών σε σειρά (LC-MS)
Translated title:
Method development and validation for the migration study of leachable species from the container of a voriconazole drug by liquid chromatography coupled with mass spectrometry (LC-MS).
Summary:
The purpose of this MSc thesis is the development and validation of an analytical method for the determination of the organic species that migrate from the final packaging into a voriconazole product, by using a Liquid Chromatography coupled to Mass Spectrometry (LC-MS) method.
More specifically, an analytical SPE-HPLC/MS method for the simultaneous determination of leachables species was developed and validated. The conditions for the solid phase extraction (SPE) were determined and the total recoveries of the analytes (%Recovery) in the sample were calculated.
During the method validation, the analytical characteristics of the method were evaluated. The examined parameters were the system suitability, the linearity, the trueness, the repeatability, the intermediate precision, the stability and the robustness of this method.
Finally, the method was applied for the semi-quantitation of the substances that migrate into a real drug product, which has been previous come into contact with the final packaging of the drug product. The sample was analyzed by an HPLC-MS method with electrospray ionization (ESI) in positive and negative operation modes.
Τhis migration study aims to verify the existence of leachables species at concentrations above the analytical evaluation threshold ΑΕΤgenotoxic, which defines that a substance may have genotoxic effect on human organism.
Main subject category:
Science
Keywords:
Voriconazole, migration, packaging, HPLC, MS, SPE, AET, Leachables, genotoxic effect
