Κατεύθυνση Φαρμακευτική Ανάλυση - Έλεγχος ποιότητας
Library of the School of Science

2017-07-13

2017

Kolotourou Ioanna

ΜΙΧΑΗΛ ΚΟΥΠΠΑΡΗΣ, Καθηγητής, Χημικό, ΕΚΠΑ
ΕΥΑΓΓΕΛΟΣ ΓΚΙΚΑΣ, Επίκουρος Καθηγητής, Φαρμακευτική, ΕΚΠΑ
ΙΩΑΝΝΗΣ ΝΤΟΤΣΙΚΑΣ, Επίκουρος Καθηγητής, Φαρμακευτική, ΕΚΠΑ

ΑΝΑΠΤΥΞΗ ΚΑΙ ΕΠΙΚΥΡΩΣΗ ΚΟΙΝΗΣ ΜΕΘΟΔΟΥ ΓΙΑ ΤΟΝ ΠΟΣΟΤΙΚΟ ΠΡΟΣΔΙΟΡΙΣΜΟ ΔΡΑΣΤΙΚΗΣ (ASSAY), ΠΡΟΣΜΙΞΕΩΝ (IMPURITIES) ΚΑΙ ΣΥΝΤΗΡΗΤΙΚΟΥ (ΒΕΝΖΟΪΚΟΥ ΟΞΕΟΣ) ΤΗΣ ΝΑΤΡΙΟΥΧΟΥ ΒΑΡΦΑΡΙΝΗΣ ΣΕ ΣΚΕΥΑΣΜΑ ΠΟΣΙΜΟΥ ΕΝΑΙΩΡΗΜΑΤΟΣ ΜΕ ΤΗΝ ΤΕΧΝΙΚΗ HPLC ΚΑΙ ΜΕΛΕΤΕΣ ΣΕ ΕΞΑΝΑΓΚΑΣΜΕΝΕΣ ΣΥΝΘΗΚΕΣ

Greek

DEVELOPMENT AND VALIDATION OF A COMMON METHOD FOR THE QUANTITATIVE DETERMINATION OF ACTIVE COMPOUND (ASSAY), IMPURITIES AND PRESERVATIVE (BENZOIC ACID) OF WARFARIN SODIUM IN AN ORAL SUSPENSION BY HPLC AND STUDIES IN FORCED DEGRADATION CONDITIONS

The aim of this Master Thesis was the development and validation of a common HPLC method for the determination of Warfarin Sodium, its related substances and its preservative (benzoic acid) in a pharmaceutical formulation, specifically in an oral suspension. This common method is a major advantage for a pharmaceutical laboratory, saving time and money.
Quantitative determination was performed at 283 nm using reverse phase chromatography with gradient elusion and mobile phases MeOH/H2O/CH3COOH.
Separation was performed using a Thermo, Betasil Phenyl Hexyl analytical column (dimensions: 150 x 4.6 mm, 5 μm) and a Thermo, ODS Hypersil guard column (dimensions: 10 x 4 mm, 5 μm) in a Thermo universal uniguard holder, at a flow rate of 2.0 mL/min and column temperature was 35 °C.
For the validation of the method the following parameters were examined: system suitability, specificity, linearity, accuracy, range, precision, robustness, limit of detection and limit of quantitation.
The results proved that the method is suitable for its purpose.

Science

Pharmacy

HPLC, WARFARIN, ORAL SUSPENSION

No

0

Yes

18

166

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https://pergamos.lib.uoa.gr/uoa/dl/object/1719068