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Title:Validacija metod za ovrednotenje prenosa analita avtomatskega sistema dissoBOT za teste raztapljanja farmacevtskih učinkovin in optimizacija cikla čiščenja : magistrsko delo
Authors:ID Šporin, Aljaž (Author)
ID Finšgar, Matjaž (Mentor) More about this mentor... New window
ID Majer, David (Comentor)
Files:.pdf MAG_Sporin_Aljaz_2023.pdf (8,39 MB)
MD5: B817C7FAF9836BB9FA9D1F3A48B4587A
 
Language:Slovenian
Work type:Master's thesis/paper
Typology:2.09 - Master's Thesis
Organization:FKKT - Faculty of Chemistry and Chemical Engineering
Abstract:V magistrskem delu smo določali prenos analita (CO, angl. carry over) avtomatiziranega sistema za izvajanje testov raztapljanja dissoBOT, kjer smo kot aktivni farmacevtski učinkovini (API) uporabili paracetamol (PA) in natrijev diklofenak (ND). Za oba API-ja smo izvedli delno validacijo spektrofotometrične metode UV-VIS, kjer smo preverjali mejo zaznavnosti (LOD) in mejo določljivosti (LOQ), linearno koncentracijsko območje, točnost in natančnost. Vrednosti LOD za oba API-ja so bile manjše od 0,01 mg/L. Za PA smo določili linearno koncentracijsko območje od 1,00‒30,00 mg/L, za ND pa od 0,50‒3,50 mg/L (v obeh primerih je bil kvadrat korelacijskega koeficienta večji od 0,9990 in koeficient kvalitete <1,00 %). Točnost metod smo ovrednotili z izračunom izkoristka raztopin standardov z znano koncentracijo in ju potrdili za oba API-ja (povprečni izkoristek je bil za PA 99,81 % in za ND 101,43 %). Natančnost smo ovrednotili z izračunom relativnega standardnega odmika (RSD). Obe metodi sta bili natančni z vrednostjo RSD 0,13 % za PA in 0,38 % za ND. Optimizirali smo volumen pralnega medija v obeh ciklih čiščenja, ki ju izvede sistem dissoBOT, in odmerjanje medija, kjer je dovoljeno odstopanje določeno z zahtevami Ameriške farmakopeje. Prav tako smo določili vpliv volumna (V) cikla čiščenja avtomatskega vzorčevalnika 850-DS, ki je eden izmed treh instrumentov, ki sestavljajo sistem dissoBOT, na vrednost CO. CO sistema dissoBOT, kjer je bil kot čistilni medij uporabljena voda iz pipe, je bil v primeru uporabe PA in ND nižji od 1,00 %. Določili smo vpliv V cikla čiščenja vzorčevalnika 850-DS na CO, kjer je bila vrednost CO pri V cikla čiščenja vzorčevalnika 850-DS 2 mL 1,38 %, pri V 5 mL 0,86 % in pri V 10 mL 0,32 %. CO pri V cikla čiščenja vzorčevalnika 850-DS 10 mL in dveh izvedenih ciklih čiščenja je bil manjši od 0,20 %.
Keywords:prenos analita, avtomatizacija, validacija, dissoBOT, testi raztapljanja, UV-VIS
Place of publishing:Maribor
Place of performance:Maribor
Publisher:[A. Šporin]
Year of publishing:2023
Number of pages:1 spletni vir (1 datoteka PDF (XI, 52 f.))
PID:20.500.12556/DKUM-83983 New window
UDC:544.351:615.015(043.2)
COBISS.SI-ID:152284675 New window
Publication date in DKUM:04.05.2023
Views:819
Downloads:123
Metadata:XML DC-XML DC-RDF
Categories:KTFMB - FKKT
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Licences

License:CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Link:http://creativecommons.org/licenses/by-nc-nd/4.0/
Description:The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.
Licensing start date:21.03.2023

Secondary language

Language:English
Title:Validation of the method for evaluating the carry over of the automatic system dissoBOT for dissolution testing of pharmaceutical ingredients and optimization of the cleaning cycle
Abstract:In this master thesis, the carry over (CO) of the automated dissolution testing system dissoBOT was determined. Paracetamol (PA) and diclofenac sodium (ND) were used as active pharmaceutical ingredients (APIs). Partial method validation was performed for both APIs, where the limit of detection (LOD), the limit of quantification (LOQ), linear concentration range, accuracy, and precision were determined. The determined values of LOD for both APIs were less than 0.01 mg/L. The linear concentration ranges for PA and ND were 1.00‒30.00 mg/L and 0.50‒3.50 mg/L, respectively (the square of the correlation coefficient was greater than 0.9990, and the quality coefficient was less than 1.00 % for both APIs). The accuracy of the method was evaluated by calculating the recovery of the solutions of standards with known concentrations. The methods for both APIs were accurate (the average recoveries for PA and ND were 99.81% and 101.43%, respectively). The precision was evaluated by calculating the relative standard deviation (RSD). The method for PA and ND were deemed to be precise, with RSD values of 0.13% and 0.38%, respectively. The volume of rinse media in both cleaning cycles performed by the dissoBOT system and the media dispensing were optimized in accordance with the requirements of the United States Pharmacopeia. The effect of the volume (V) of the cleaning cycle of the automatic sampler 850-DS, one of the three instruments comprising the dissoBOT system, on CO was also determined. CO of the system dissoBOT, where the tap water was used as the rinse media, was lower than 1.00% in the case of PA and ND. We have determined the influence of the 850-DS autosampler's cleaning cycle V on the CO for PA. The results showed that the CO was 1.38% for a V of 2 mL, 0.86% for 5 mL, and 0.32% for 10 mL.. The CO of the system dissoBOT was lower than 0.20% for 10 mL of the 850-DS autosampler’s cleaning cycle and two cleaning cycles performed for PA.
Keywords:carry over, automation, validation, dissoBOT, dissolution tests, UV-VIS


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