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Title:Preverjanje ustreznosti analitske metode za določanje vsebnosti aktivnih učinkovin
Authors:Proje, Nika (Author)
Finšgar, Matjaž (Mentor) More about this mentor... New window
Sušec, Maja (Co-mentor)
Files:.pdf UN_Proje_Nika_2019.pdf (2,17 MB, This file will be accessible after 04.09.2022)
 
Language:Slovenian
Work type:Bachelor thesis/paper (mb11)
Typology:2.11 - Undergraduate Thesis
Organization:FKKT - Faculty of Chemistry and Chemical Engineering
Abstract:Diplomsko delo preverja ustreznost analitske metode za določanje vsebnosti aktivnih učinkovin v izbranem zdravilu. Ustreznost metode za testiranje stabilnosti zdravil se preveri s pomočjo prisilnega oz. pospešenega razkroja aktivnih farmacevtskih učinkovin, zato je namen diplomskega dela določiti stresne pogoje, ki povzročajo razkroj, ter ovrednotiti spremembe vsebnosti aktivnih učinkovin. Za vse teste smo pripravili vzorce placeba, aktivnih učinkovin A in B ter vzorce zdravila. Vzorce smo izpostavili okolju prisilne oksidacije (0,03 % H2O2, sobna temperatura, 1 ura), povišani temperaturi za različne čase (raztopina, 60 °C, 1 ura, 1 ura 30 min, 2 uri), bazični hidrolizi z različnimi množinskimi koncentracijami baze (0,005 mol/L, 0,010 mol/L, 0,050 mol/L NaOH, sobna temperatura, 5 min) ter kislinski hidrolizi z različnimi množinskimi koncentracijami kisline (0,005 mol/L, 0,010 mol/L, 0,050 mol/L HCl, sobna temperatura, 20 min). Vzorce, izpostavljene stresnim pogojem, smo primerjali z nerazkrojenimi vzorci ter tako ugotavljali, kako različni stresni pogoji vplivajo na vsebnost aktivnih farmacevtskih učinkovin. Spremembe vsebnosti smo spremljali s HPLC-metodo, pri čemer smo ugotovili, da je izmed dveh aktivnih učinkovin zdravila učinkovina A ob izbranih stresnih pogojih manj dovzetna za razkroj od učinkovine B. Zanimivo je bilo spoznanje, da je aktivna učinkovina A bolj stabilna sama, nasprotno pa je učinkovina B bolj stabilna v zdravilu, torej v kombinaciji z učinkovino A in komponentami placeba. V vzorcih placeba, kot pričakovano, ni bilo prisotnih aktivnih farmacevtskih učinkovin. Ugotovili smo, da je analitska metoda za določanje vsebnosti aktivnih učinkovin A in B ustrezna za testiranje stabilnosti in kakovosti zdravila, saj z njo lahko zaznamo padce vsebnosti aktivnih farmacevtskih učinkovin.
Keywords:HPLC, ustreznost analitske metode, vsebnost aktivnih učinkovin, stresni testi, razkroj vzorcev
Year of publishing:2019
Source:Maribor
NUK URN:URN:SI:UM:DK:YEYZDEHP
License:CC BY-NC-ND 4.0
This work is available under this license: Creative Commons Attribution Non-Commercial No Derivatives 4.0 International
Views:32
Downloads:0
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Categories:KTFMB - FKKT
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Secondary language

Language:English
Title:Stability indicating test of analytical method for the assay determination of active pharmaceutical ingredients
Abstract:This diploma thesis presents stability indicating test of analytical method for the assay determination of active pharmaceutical ingredients in selected drug product. The suitability of this method is demonstrated with forced degradation of active pharmaceutical ingredients; therefore, the purpose of this diploma thesis is to determinate stress conditions that cause degradation and to evaluate the decrease of active ingredients assay. For all the tests we prepared placebo samples, samples of active substances A and B, and samples of a drug product. We exposed samples to oxidative condition (0,03 % H2O2, ambient temperature, 1 hour), to high temperature for various times (solution, 60 °C, 1 hour, 1 hour 30 min, 2 hours), to alkaline hydrolysis with various molar concentrations of base (0,005 mol/L, 0,010 mol/L, 0,050 mol/L NaOH, ambient temperature, 5 min) and to acid hydrolysis with various molar concentrations of acid (0,005 mol/L, 0,010 mol/L, 0,050 mol/L HCl, ambient temperature, 20 min). The samples that were exposed to stress conditions were compared with non-degraded samples to determine how different stress conditions affect the assay of active pharmaceutical ingredients. For monitoring the changes of assay, HPLC method was used and we found out that, from the two active ingredients of the drug product, the active substance A was less sensitive to the selected stress conditions than the active substance B. It is interesting that the active substance A is more stable as substance and on the contrary the active substance B is more stable in a drug product in combination with the active substance A and the components of placebo. As expected, no active pharmaceutical ingredients were present in placebo samples. The analytical method for the assay determination of active ingredients A and B is stability indicating as it can detect the decrease of the assay of active pharmaceutical ingredients.
Keywords:HPLC, stability indicating test of analitical method, assay of active ingredients, stress tests, sample degradation


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