Unit:
Κατεύθυνση Χημική Ανάλυση-Έλεγχος ΠοιότηταςLibrary of the School of Science
Author:
Μπούμπαλος Αθανάσιος
Supervisors info:
Μιχαήλ Κουππάρης Καθηγητής ΕΚΠΑ (Επιβλέπων), Ευάγγελος Γκίκας Λέκτορας ΕΚΠΑ, Ιωάννης Ντότσικας Λέκτορας ΕΚΠΑ
Original Title:
Ανάπτυξη και επικύρωση μεθόδων HPLC για ποσοτικό προσδιορισμό και έλεγχο προσμίξεων του υπεροξειδίου του βενζοϋλίου σε φαρμακευτικά σκευάσματα
Translated title:
Determination assay of Benzoyl peroxide (BPO) and of its related substances in α pharmaceutical cream using a new validated HPLC method
Summary:
Aim of this project is the assay of Benzoyl peroxide (BPO) and the
determination of its related substances in a cream used against acne using a
new validated HPLC method in the place of the existing for related substances
thin layer chromatographic method as it is described in Eu. Ph.
The chromatographic conditions are as follows: HPLC system with photodiode
array detector; column Spherisorb ODS-1 250 4.6 mm, 10 μm; mobile phase: a
mixture of glacial acetic acid, ACN and water (1:500:500 V/V/V); Injection
volume: 20 μL ; flow rate: 1.0 mL min-1; autosampler temperature: ambient; run
time: 30 min; quantification wavelength: 235 nm
A factorial experimental design for the optimization of the sample treatment of
the cream was used.
The newly developed HPLC method was validated in terms of analytical
characteristics according to ICH, such as linearity, precision, accuracy,
specificity, robustness and quantification, and detection limits.
Keywords:
Validation, HPLC , Benzoyl peroxide, Impurities, Forced degradation studies
Number of index pages:
1-10
