Unit:
Κατεύθυνση Φαρμακευτική Ανάλυση-Έλεγχος ΠοιότηταςLibrary of the School of Science
Supervisors info:
Ιωάννης Λουκάς, Αναπληρωτής Καθηγητής Τμήμα Φαρμακευτικής, ΕΚΠΑ,
Κωνσταντίνος Γεωργακόπουλος, Αναπληρωτής Καθηγητής Τμήμα Φαρμακευτικής, ΕΚΠΑ,
Ιωάννης Ντότσικας, Αναπληρωτής Καθηγητής Τμήμα Φαρμακευτικής, ΕΚΠΑ
Original Title:
ΑΝΑΠΤΥΞΗ ΚΑΙ ΕΠΙΚΥΡΩΣΗ ΝΕΑΣ ΜΕΘΟΔΟΥ HPLC ΓΙΑ ΤΟΝ ΠΡΟΣΔΙΟΡΙΣΜΟ ΠΡΟΣΜΙΞΕΩΝ ΜΕΤΡΟΝΙΔΑΖΟΛΗΣ ΣΕ ΔΙΣΚΙΑ
Translated title:
DEVELOPMENT AND VALIDATION OF A NEW HPLC METHOD FOR THE DETERMINATION OF METRONIDAZOLE IMPURITIES IN TABLETS
Summary:
The purpose of this thesis was the development and validation of an HPLC method for
the accurate and reliable determination of impurities of the active substance Metronidazole in
Bismuth potassium hypocitrate 140 mg/ Metronidazole 125 mg/ Tetracycline hydrochloride 125
mg tablets or capsules. The specific formulation with the above combination of active
pharmaceutical compounds is used to treat peptic ulcer (duodenal) caused by the pathogenic
bacterium Helicobacter pylori. The method chosen was based on the principles of reverse
phase chromatography with the addition of perchlorates in mobile phase to create ion pairs.
The column used was an ACE 3 C18-PFP, 150 × 4.6 mm, 3 μm at a temperature of 25 °C and a
mobile phase flow rate of 0.6 mL/min. Mobile phase A consisted of buffer solution pH
3.20/Methanol 95/5 v/v, while mobile phase B of Methanol/Acetonitrile 50/50 v/v. A gradient
elution program with a total run time of 47 min and a determination wavelength of 315 nm was
selected. The validation of the method was based on the ICH guidelines which include
specificity, linearity, repeatability, accuracy and stability of solutions.
Main subject category:
Science
Other subject categories:
Health Sciences
Keywords:
HPLC, Metronidazole, Impurities
