title: Development of a gradient HPLC method for the simultaneous determination of sotalol and sorbate in oral liquid preparations using solid core stationary phase.
abstract: A selective and sensitive gradient HPLC-UV method for quantification of sotalol hydrochloride and potassium sorbate in five types of oral liquid preparations was developed and fully validated. The separation of an active substance sotalol hydrochloride, potassium sorbate (antimicrobial agent), and other substances (for taste and smell correction, etc.) was performed using an Ascentis Express C18 (100 × 4.6 mm, particles 2.7 μm) solid core HPLC column. Linear gradient elution mode with a flow rate of 1.3 mL min(-1) was used, and the injection volume was 5 µL. The UV/Vis absorbance detector was set to a wavelength of 237 nm, and the column oven was conditioned at 25°C. A sodium dihydrogen phosphate dihydrate solution (pH 2.5; 17.7 mM) was used as the mobile phase buffer. The total analysis time was 4.5 min (+2.5 min for reequilibration). The method was successfully employed in a stability evaluation of the developed formulations, which are now already being used in the therapy of arrhythmias in pediatric patients; the method is also suitable for general quality control, that is, not only just for extemporaneous preparations containing the mentioned substances.
authors: Department of Analytical Chemistry, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic.
authors: Ludmila
authors: 0000-0001-9879-6008
authors: L
authors: Matysova
authors: Department of Analytical Chemistry, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic.
authors: Oxana
authors: 0000-0001-5785-2851
authors: O
authors: Zahalkova
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic ; Hospital Pharmacy, University Hospital in Motol, 150 06 Prague 5, Czech Republic.
authors: Sylva
authors: 0000-0003-4087-9251
authors: S
authors: Klovrzova
authors: Department of Pharmaceutical Technology, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic.
authors: Zdenka
authors: 0000-0001-9314-705X
authors: Z
authors: Sklubalova
authors: Department of Analytical Chemistry, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic.
authors: Petr
authors: 0000-0003-4611-2051
authors: P
authors: Solich
authors: Department of Analytical Chemistry, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic.
authors: Lukas
authors: 0000-0002-5320-0300
authors: L
authors: Zahalka