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Title:
RAZVOJ HPLC METODE ZA DOLOČANJE NEČISTOT V ZDRAVILNI UČINKOVINI
Authors:
ID
Grmek, Damijan
(Author)
ID
Brodnjak-Vončina, Darinka
(Mentor)
More about this mentor...
ID
Kolar, Mitja
(Comentor)
ID
Naveršnik, Klemen
(Comentor)
Files:
VS_Grmek_Damijan_2011.pdf
(1,08 MB)
MD5: C3411B993963FE411EB59C8ADD88CA6E
PID:
20.500.12556/dkum/9920a3ac-ecf1-499b-89bd-2c2641144000
Language:
Slovenian
Work type:
Undergraduate thesis
Organization:
FKKT - Faculty of Chemistry and Chemical Engineering
Abstract:
Razvoj analiznih metod za aktivne farmacevtske učinkovine je eden od začetnih in odločilnih korakov v farmacevtskem razvoju, še posebno takrat, kadar za izbrani produkt ni na voljo dovolj podatkov iz literature. Na področju stabilnosti se v začetnih fazah razvoja spremljajo predvsem vsebnosti nečistot, za kar potrebujemo ustrezno analizno metodo. Namen diplomskega dela je bil razviti metodo tekočinske kromatografije visoke ločljivosti (HPLC), s katero bomo vrednotili sorodne snovi in razkrojne produkte v substanci. Metodo smo razvili na osnovi ameriške (USP) in evropske (PhEur) farmakopeje - farmakopejskih metod za kemijsko sorodno substanco in jo optimizirali za potrebe spremljanja sorodnih snovi in razkrojnih produktov v naši substanci. Obstoječi farmakopejski metodi nista ustrezali zaradi predolgega časa analize, kar ni primerno za večje število vzorcev. Predvsem smo raziskali vpliv različnih kromatografskih pogojev: mobilnih faz, separacijskih kolon, temperature kolone in spreminjanja gradienta. S stresnimi testiranji smo preučili občutljivost substance na vpliv svetlobe, temperature in vlage, vpliv prisotnosti kislin, baz in oksidantov. Razvito metodo smo v nadaljevanju tudi validirali. Za testiranje v laboratorijski fazi bi bila celotna validacija predolga, zato smo se odločili za testiranje ključnih validacijskih parametrov. Na osnovi rezultatov validacije analizne metode smo dokazali, da je nova HPLC metoda primerna za preverjanje sorodnih snovi v zdravilni učinkovini.
Keywords:
HPLC
,
analizni postopek
,
instrumentalna metoda
,
validacija
,
zdravilna učinkovina
Place of publishing:
Maribor
Publisher:
[D. Grmek]
Year of publishing:
2011
PID:
20.500.12556/DKUM-18892
UDC:
543.544.5.068.7(043.2)
COBISS.SI-ID:
15159574
NUK URN:
URN:SI:UM:DK:F7O3XCRB
Publication date in DKUM:
23.06.2011
Views:
7022
Downloads:
1535
Metadata:
Categories:
KTFMB - FKKT
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:
GRMEK, Damijan, 2011,
RAZVOJ HPLC METODE ZA DOLOČANJE NEČISTOT V ZDRAVILNI UČINKOVINI
[online]. Bachelor’s thesis. Maribor : D. Grmek. [Accessed 18 April 2025]. Retrieved from: https://dk.um.si/IzpisGradiva.php?lang=eng&id=18892
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Secondary language
Language:
English
Title:
DEVELOPMENT OF HPLC METHOD FOR DETERMINATION OF IMPURITIES IN ACTIVE INGREDIENT
Abstract:
Development of analytical methods for active pharmaceutical ingredients is one of the initial and crucial steps in pharmaceutical development, especially when not enough data from the literature is available for the selected product. In the area of stability in the early stages of development an appropriate method is required to detect impurities. The purpose of this thesis was to develop a high performance liquid chromatography method (HPLC) to monitor related substances and degradation products in active ingredient. The developed method is based on the United States Pharmacopeia (USP) and European Pharmacopoeia (PhEur) - pharmacopoeia methods for a similar substance and was optimized for the monitoring of related substances and degradation products. The existing pharmacopoeia methods did not suit us in terms of longer time of analysis, which was not convenient for larger number of samples. In particular, we studied the effect of different chromatographic conditions: mobile phase, different separation columns, column temperature and changing of the gradient. Sensitivity to light, temperature and humidity and the influence of the presence of acids, bases and oxidants were studied using stress stability testing. Finally, the method was also validated. For testing in the laboratory phase, the entire validation process would be too long, so we decided to validate only key parameters. Based on the results of the validation, we demonstrated that the new HPLC method is suitable for verification of related substances in active ingredient.
Keywords:
HPLC
,
analytical procedure
,
instrumental method
,
validation
,
active ingredient
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