Simultaneous Determination of Propranolol Hydrochloride and Sodium Benzoate in Oral Liquid Preparations by HPLC
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A simple, selective and sensitive HPLC–UV method for quantification of propranolol hydrochloride and sodium benzoate in oral liquid preparations was developed and fully validated. Separation was performed by Supelco Discovery® C18 (25 cm × 4.6 mm, particles 5 μm) column. UV/VIS absorbance detector was set at wavelength 230 nm. Column oven was conditioned to 25 °C. Mobile phase was prepared by dissolving 1.6 g of sodium dodecyl sulphate and 0.31 g of tetrabutylammonium dihydrogen phosphate in 450 mL of ultrapure water; 1 mL of sulphuric acid (95–97 %) and 550 mL of acetonitrile were added. Sodium hydroxide solution (2.1 M) was used for adjusting pH to value 3.3 (±0.05). Retention times of sodium benzoate, propranolol hydrochloride and butylparaben (internal standard) were 2.2, 3.3 and 4.1 min, respectively. Newly developed method is suitable for simultaneous determination of propranolol hydrochloride and sodium benzoate in oral liquid preparations which are used for therapy of haemangiomas in paediatric patients. Method has been applied for stability testing of extemporaneous paediatric oral formulations containing propranolol hydrochloride.
KeywordsHPLC Propranolol hydrochloride Sodium benzoate Paediatric oral formulations
Authors gratefully acknowledge financial support by the project for conceptual development of research organization 00064203 and by the Charles University in Prague (Project SVV 2013 267 002). The publication is co-financed by the European Social Fund and the state budget of the Czech Republic. TEAB, project no. CZ.1.07/2.3.00/20.0235.
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