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EN
A simple, reversed-phase HPLC method has been developed for rapid, simultaneous quantification of phenylephrine hydrochloride, guaiphenesin, ambroxol hydrochloride, and salbutamol (as salbutamol sulphate) in a commercial cough-cold liquid formulation. The compounds were separated on a 250 mm × 4.6 mm C8 column with a gradient prepared from pH 3.0 phosphate buffer and 1:1 methanol-acetonitrile as mobile phase at a flow rate of 1.0 mL min -1. Elution of the analytes was achieved in less than 15 min. Detection was by UV absorbance at 273 nm for phenylephrine hydrochloride and guaiphenesin and 225 nm for ambroxol hydrochloride and salbutamol. Percentage recovery and RSD were, respectively, 100.09% and 0.22% for phenylephrine hydrochloride, 100.43% and 0.50% for guaiphenesin, 100.91% and 0.70% for ambroxol hydrochloride, and 100.54% and 0.55% for salbutamol. The components of the syrup formulation were quantified on the basis of the peak areas obtained from freshly prepared standard solutions. The method was validated in accordance with ICH guidelines.
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