diplomsko delo visokošolskega študijskega programa
Bojan Lenček (Avtor), Darinka Brodnjak-Vončina (Mentor), Mitja Kolar (Komentor)

Povzetek

V sodobni družbi se iz dneva v dan srečujemo z novimi tehnologijami, ki nam na eni strani omogočajo povečanje produktivnosti ter učinkovitosti, na drugi strani pa zmanjšanje porabe energije in so okolju bolj prijazne. Tekočinska kromatografija visoke ločljivosti (HPLC) je visoko razvita tehnika, ki se uporablja v zadnjih 30 letih v analiznih laboratorijih širom po svetu. Eden glavnih gonilnikov za rast te tehnologije je bil razvoj stacionarnih faz, ki se uporabljajo za namen separacije. Tekočinska kromatografija ultra visoke ločljivosti (UPLC) je bila uspešno sprejeta v laboratorijih po vsem svetu za najbolj zahtevne separacije, je zelo robustna, zanesljiva in ponovljiva tehnika. Glavna razlika med sistemoma, ki ju obravnavam v diplomskem delu je v stacionarni fazi, kjer sub-2-µm delci ponujajo pomembne prednosti pred obstoječo HPLC tehniko, ki je standardno opremljena s 5-µm delci. Pri uporabi UPLC tehnike se zmanjša čas analize in na ta način predvsem stroškov na vzorec (manjša poraba topila in energije), obenem pa se poveča kromatografska hitrost, resolucija in občutljivost ter se zelo zmanjša tudi mrtvi volumen sistema. Na podlagi obstoječe HPLC analizne metode za določanje vsebnosti aktivne učinkovine v kapsulah smo za potrebe novega instrumenta razvili novo UPLC analizno metodo. Izvedli smo primerjalni analizi ter ovrednotili pridobljene rezultate. Z uporabo statističnih testov smo dokazali primerljivost obeh analiznih metod. Glede na to, da se lahko za preizkušanje zdravil uporabljajo samo validirane metode, smo se lotili validacije nove UPLC metode. Potrditev nove UPLC analizne metode je bila opravljena in ovrednotena v skladu s predpisanimi postopki in merili sprejemljivosti. Na osnovi rezultatov validacije analizne metode smo dokazali, da je nova UPLC metoda primerna za rutinsko preverjanje vsebnosti aktivne učinkovine v kapsulah.

Ključne besede

analizni postopki;instrumentalna metoda;validacija;aktivne učinkovine;

Podatki

Jezik: Slovenski jezik
Leto izida:
Izvor: Maribor
Tipologija: 2.11 - Diplomsko delo
Organizacija: UM FKKT - Fakulteta za kemijo in kemijsko tehnologijo
Založnik: [B. Lenček]
UDK: 543.544.5(043.2)
COBISS: 15003158 Povezava se bo odprla v novem oknu
Št. ogledov: 3367
Št. prenosov: 394
Ocena: 0 (0 glasov)
Metapodatki: JSON JSON-RDF JSON-LD TURTLE N-TRIPLES XML RDFA MICRODATA DC-XML DC-RDF RDF

Ostali podatki

Sekundarni jezik: Angleški jezik
Sekundarni naslov: UPLC method development for determination of an active substance in capsules
Sekundarni povzetek: Nowadays we are facing day by day with new technologies, which allow us to increase our productivity and efficiency and on the other hand also allow us to reduce energy consumption and are more environmentally friendly. High Performancce Liquid Chromatography (HPLC) is a proven technicque that has been used in laboratories worlwide over the past 30-plus years. One of the primary drivers for the growth of this technicque has been the evolution of packaging used to effect the separation. Ultra Performancce Liquid Chromatography (UPLC), which has been adopted successfully in laboratories around the world for the most demanding separations, is a highly robust, dependable, and reproducible technicque. What differentiates the system’s holistic design is sub-2-μm hybrid particle chemistry, which offers significant benefits over today's HPLC systems equipped with standard 5-μm particle chemistries. The UPLC system eliminate significant time and cost per sample from our analytical process (reduce solvent and energy consumption) while improving the quality of our results. By outperforming traditional or optimized HPLC, the system allows chromatographers to work at higher efficiencies with a much wider range of linear velocities, flow rates, and backpressures. In order to implement UPLC method for the determination of assay of active substance in the capsules, we based on existing analytical procedure developed a new instrumental method. When we managed to develop a new UPLC method, we performed a comparison between the analytical results obtained with the existing HPLC method and new UPLC method. Using statistical tests, we demonstrated the comparability of both methods. Given that for drug testing may be used only validated methods, we also validate the new UPLC method. Validation of the new UPLC method was performed and evaluated in accordance with prescribed procedures and acceptance criteria. Based on the results of the validation of the method, we demonstrated that the new UPLC method could be used for routine testing of assay of active substance in the capsules.
Sekundarne ključne besede: HPLC;UPLC;analytical procedure;instrumental method;validation;active substance;
URN: URN:SI:UM:
Vrsta dela (COBISS): Diplomsko delo
Komentar na gradivo: Univ. v Mariboru, Fak. za kemijo in kemijsko tehnologijo
Strani: XIII, 69 f.
Ključne besede (UDK): mathematics;natural sciences;naravoslovne vede;matematika;chemistry;crystallography;mineralogy;kemija;analytical chemistry;analizna kemija;physicochemical methods of analysis (other than optical methods);
ID: 1000426