| Abstract (croatian) | Cilj: Plinska kromatografija s masenom spektrometrijom (GC-MS) osjetljiva je i selektivna metoda s potencijalom za standardno određivanje rokuronijeva bromida u plazmi. Primjenom u postupcima izvantjelesne membranske oksigenacije (engl. Extracorporeal Membrane Oxygenation; ECMO) možemo utvrditi utjecaj na koncentracije lijekova. Ciljevi rada bili su ispitati primjerenost GC-MS metode za određivanje rokuronijeva bromida u plazmi te usporediti njegove venske i arterijske koncentracije kod pacijenata s ECMO potporom. Materijali i metode: Korištene su standardne otopine različitih omjera, plazma te otopina rokuronijeva bromida (Esmeron, 10 mg/ml, N. V. Organon, Nizozemska), etanol, diklormetan, natrijev dihidrogenfosfat, kalijev jodid, voda, aceton. GC-MS metoda provedena je u Nastavnom zavodu za javno zdravstvo PGŽ-a, a klinički dio na pet slučajno odabranih pacijenata liječenih ECMO potporom u KBC-u Rijeka. Rezultati: Dobiveni su validacijom: GD 0,553 μg/ml, GK (potvrđen) 5 μg/ml, preciznost RSD = 2,083 % (RSD ≤ 10 %), intermedijarna preciznost RSD = 3,05 % (RSD ≤ 10 % ), točnost 98,9 % (90 – 110 %), koeficijent korelacije r = 0,9961 (r ≥ 0,995), selektivnost metode – RT = 23,25 min, m/z = 413. Klinička vrijednost metode potvrđena je mjerenjem koncentracija rokuronijeva bromida kod pacijenata s ECMO potporom. Sve vrijednosti bile su više u venskom nego u arterijskom uzorku u svim mjerenjima. Zaključci: Validacijom GC-MS metode potvrđeno je kako se validacijski parametri nalaze u kriteriju prihvatljivosti te je metoda primjenjiva za određivanje rokuronijeva bromida u plazmi. ECMO potpora smanjuje razinu lijeka u arterijskom uzorku, ali zbog malog broja uzoraka i velike varijabilnosti u koncentraciji nije postignuta statistički značajna razlika. |
| Abstract (english) | Objective: Gas chromatography with mass spectrometry (GC-MS) is a sensitive and selective method with the potential for standard determination of rocuronium bromide in plasma. The use of Extracorporeal Membrane Oxygenation (ECMO) can be used to determine the effect on drug concentrations. The aim of the study was to examine the suitability of the GC-MS method for the determination of rocuronium bromide in plasma and to compare its venous and arterial concentrations in patients with ECMO support. Materials and methods: Standard solutions of different ratios, plasma and rocuronium bromide solution (Esmeron, 10 mg/ml, N.V. Organon, The Netherlands), ethanol, dichloromethane, sodium dihydrogen phosphate, potassium iodide, water, acetone were used. GC-MS was performed in the Teaching Institute for Public Health Rijeka, and the clinical part on five randomly selected patients treated with ECMO support in University hospital of Rijeka. Results: obtained by validation are: GD 0.553 μg/ml, GK (confirmed) 5 μg/ml, accuracy RSD = 2.083% (RSD ≤ 10%), intermediate accuracy RSD = 3.05% (RSD ≤ 10%), accuracy 98.9% (90 – 110%), correlation coefficient k = 0.9961 (r ≥ 0.995), selectivity of the method – RT = 23.25 min, m/z = 413. The clinical value of the method was confirmed by measuring the concentrations of rocuronium bromide in patients with ECMO support. Rocuronium bromide values were higher in the venous than in the arterial sample in all measurements. Conclusions: Validation of the GC-MS method confirmed that all performed validation parameters are in the acceptance criterion and the method is applicable for the determination of rocuronium bromide. ECMO support reduces the drug level in the arterial sample, but due to the small number of samples and high variability in concentration, no statistically significant difference was achieved. |
