期刊
JOURNAL OF ANALYTICAL METHODS IN CHEMISTRY
卷 2015, 期 -, 页码 -出版社
HINDAWI LTD
DOI: 10.1155/2015/806736
关键词
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资金
- Charles University in Prague [GAUK 1472213]
- Czech Ministry of Education, Youth and Sports [SVV 260 183, SVV 260 184]
- MH CZ-DRO, University Hospital in Motol, Prague, Czech Republic [00064203]
- European Social Fund
- State Budget of the Czech Republic, TEAB [CZ.1.07/2.3.00/20.0235]
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 x 4.6 mm, particles 2.7 mu m) 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 mu L. The UV/Vis absorbance detector was set to a wavelength of 237 nm, and the column oven was conditioned at 25 degrees 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.
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