Comparative study of orthogonal chromatographic / spectrometric methodologies for the determination of octreotide acetate for injectable suspension impurity profil

Postgraduate Thesis uoadl:2865777 228 Read counter

Unit:
Κατεύθυνση Φαρμακευτική Ανάλυση - Έλεγχος ποιότητας
Library of the School of Science
Deposit date:
2019-03-12
Year:
2019
Author:
Marmarinou Evangelia
Supervisors info:
Ευάγγελος Γκίκας, Επίκουρος Καθηγητής του Τομέα Φαρμακευτικής Χημείας, ΕΚΠΑ
Ιωάννης Ντότσικας, Επίκουρος Καθηγητής του Τομέα Φαρμακευτικής Χημείας, ΕΚΠΑ
Ειρήνη Παντερή, Καθηγήτρια του Τομέα Φαρμακευτικής Χημείας, ΕΚΠΑ
Original Title:
Συγκριτική μελέτη ορθογώνιων χρωματογραφικών / φασματομετρικών μεθοδολογιών για τον προσδιορισμό προσμίξεων σε ενέσιμα εναιωρήματα οξικής οκτρεοτίδης
Languages:
Greek
Translated title:
Comparative study of orthogonal chromatographic / spectrometric methodologies for the determination of octreotide acetate for injectable suspension impurity profil
Summary:
Generic drugs are a field that has been used by many pharmaceutical companies in recent years. This diploma thesis focuses on the brand name drug Sandostatin® LAR and the generic drug of octreotide acetate. In the first chapter, the concepts of generic and bioequivalence, which is the basic prerequisite for the development of generic drugs, are mentioned. Subsequently, long acting injectables and methods of microparticle production are analyzed. Particular emphasis is placed on therapeutic, bioactive peptides and the meaning of quality, an integral part of each drug, which is directly related to the control of by-products of new pharmaceutical formulations.
The experimental part of this thesis, presents the development of three orthogonal analytical methods for quantification of impurities in long acting injectables of the original drug. The study of the impurity profile was carried out on samples near their release date and close to their expiry date. All identified and quantitated impurities were within the permissible limits, thus giving the particular drug high quality, safety and efficacy characteristics.
In conclusion, this diploma thesis highlights the importance of controlling the by-products of new pharmaceutical drugs and the great contribution of analytical methods to this purpose.
Main subject category:
Science
Keywords:
generic drugs, orthogonal chromatographic methods, determination of impurities, octreotide acetate
Index:
Yes
Number of index pages:
5
Contains images:
Yes
Number of references:
53
Number of pages:
109
File:
File access is restricted only to the intranet of UoA.

master_final.pdf
3 MB
File access is restricted only to the intranet of UoA.