Development and validation of analytical methods for the determination of the active substance metformin and its related substances and excipients, in oral solution, using High Performance Liquid Chromatography

Postgraduate Thesis uoadl:2775824 265 Read counter

Unit:
Κατεύθυνση Χημική Ανάλυση-Έλεγχος Ποιότητας
Library of the School of Science
Deposit date:
2018-06-27
Year:
2018
Author:
Mpoutsini Katerina
Supervisors info:
Κουππάρης Μιχαήλ, Καθηγητής, Χημείας, Θετικών επιστημών
Original Title:
Ανάπτυξη και επικύρωση μεθόδων για τον προσδιορισμό μετφορμίνης, συγγενών ουσιών και εκδόχων σε πόσιμο διάλυμα με υγροχρωματογραφία υψηλής απόδοσης
Languages:
Greek
Translated title:
Development and validation of analytical methods for the determination of the active substance metformin and its related substances and excipients, in oral solution, using High Performance Liquid Chromatography
Summary:
Diabetes mellitus is a chronic condition which is classified in metabolic disorder diseases. The two major types of diabetes are: type 1 diabetes or insulin-dependent diabetes, in which there is no production of insulin and type 2 diabetes or insulin-independent diabetes, in which the production of insulin is unsatisfactory.
Type 2 diabetes is characterized as "the great threat" of the future due to the rapid increase of the cases. Early diagnosis combined with proper nutrition and treatment can regulate the disease.
Metformin is an antiglycemic drug of the bigouanides group, that is used for the control of type 2 diabetes. It originates from the plant Galega officinalis and has been used for the treatment of diabetes since 1957. Clinical trials continually show the multiple benefits of metformin, which is identified as the antidiabetic drug of choice.
The subject of this MSc thesis was the development and validation of analytical methods for the determination of the active substance metformin and its related substances and excipients (parabens), in oral solution, using High Performance Liquid Chromatography technique with a Photo Diode-Array detector (PDA) detector. Forced degradation studies were also conducted, in order to further evaluate the selectivity of the methods.
During method validation, appropriate quality characteristics were investigated, such as linearity, precision, accuracy, robustness and limits of detection-quantification. All methods were found adequate for the intended use.
Main subject category:
Science
Keywords:
Metformin, validation, HPLC, drug, Diabetes mellitus
Index:
Yes
Number of index pages:
5
Contains images:
Yes
Number of references:
96
Number of pages:
163
File:
File access is restricted only to the intranet of UoA.

ΜΠΟΥΤΣΙΝΗ ΑΙΚΑΤΕΡΙΝΗ.pdf
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File access is restricted only to the intranet of UoA.