Abstract
The applicability of liquid chromatography‐atmospheric‐pressure chemical‐ionization‐mass spectrometry (LC‐APCI‐MS) for the determination of 13C‐urea in 13C‐urea/PEG capsules has been studied. It is essential to assess the stability of a newly developed low‐dose (38 mg) 13C‐urea/PEG capsule, which will be used for a 13C‐urea breath test (13C‐UBT) to detect Helicobacter pylori infection. A standard curve was linear over the concentration range 10–1000 µg/mL. Intra‐ and inter‐day variations were less than 2.75% in APCI‐MS. The detection limit was 10 pg when selected ion monitoring (SIM) was employed. The content of 13C‐urea in capsules was within the acceptable range between 95 and 105%. Therefore, it was established that 13C‐urea/PEG capsules were stable under an accelerated stability condition that was set at 40 ± 2°C with relative humidity of 75 ± 5%, during six months by using LC‐APCI‐MS. This research is the first report that describes LC‐APCI‐MS analysis of 13C‐urea capsules.
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