Objective To establish a highly specific method for the determination of related substances in salbutamol sulfate injection.Methods HPLC was performed on a column packed with spherical end-capped octylsilyl silica gel(Hypersil BDS C8 4.6×150 mm,3 μm)at the flow rate of 0.6 mL/min,the detection wavelength of 220 nm and column temperature of 25℃by gradient elution using 3.45 g/L sodium dihydrogen phosphate dihydrate solution(adjust to pH 3.0 with phosphoric acid)as mobile phase A,10 volumes of methanol and 90 volumes of acetonitrile as mobile phase B.Results The chromatograph showed good specificity of the peaks of main components and 15 impurities,and the method verification of 6 of the impurities showed good linear,repeatability and recovery.Conclusion The chromatographic peaks of the main components in salbutamol can be completely separated from the 15 impurities.The established method is highly specific,easy to operate and can be used for the inspection of related substances in salbutamol sulfate injection.
salbutamol sulfateinjectionmethods for the detection of substancesHPLC
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