HPLC determination of preservative contents in ambroxol hydrochloride oral liquid preparations

Objective:To establish a high performance liquid chromatography-diode array detection(HPLC-DAD) method to simultaneously determine nine kinds of preservatives in ambroxol hydrochloride oral solution and syrup.Methods:The method was conducted on an Agilent ZORBAX Eclipse XDB C18 column(50 mm×4.6 mm,1.8 μm) with phosphate buffered solution and acetonitrile as mobile phase,by gradient elution at a flow rate of 1.5 mL·min-1.The column temperature was set at 40 ℃.The interference of impurity peaks was eliminated by adjusting the pH of buffer solution in the mobile phase.The quantitative wavelength was the maximum absorption wavelength of each component.Results:Complete separation of nine kinds of preservatives was achieved with fine peak shapes.The calibration curves were linear in the range of 2-100 μg·mL-1(r≥0.999).The average recoveries were between 98% and 102%,and the RSD was less than 2%.Conclusion:The method was convenient,rapid,with good separation,which can be used for screen and quantitatively determination of preservatives in ambroxol hydrochloride oral liquid preparations.