HPLC Study of the Related Substances in Procatterol Hydrochloride Tablets
Objective:To establish an HPLC method for the related substances test in procaterol hy-drochloride tablets.Methods:An Inertsil ODS-3 column(4.6 mm×150 mm,5 μm)was used for the separa-tion by using 10 mmol·L-1 sodium octanesulfonate(the pH value was adjusted to 2.90 by 10%phosphoric acid solution)as mobile phase A and mixed water-acetonitrile solvent(43∶57,V∶V)as mobile phase B for gradient elution at a flow rate of 1.0 mL·min-1.The column temperature was maintained at 40℃ and the UV detection wavelength was set at 254 nm with an injection volume of 50 μL.Results:Procatterol hy-drochloride was well separated from its related substances A,B and C.The peak area responses of the impurities were linear with their mass concentrations in the range of 10-50 ng·mL-1(r>0.9990).And the correction factors were 0.5,1.0 and 0.4 for impurity A,B and C,respectively.The average recoveries were 95.0%-105.0%(n=9,RSD<3.0%).Conclusion:The established HPLC method was suitable for the test of the related substances in procaterol hydrochloride tablets,and useful for the revision of the quality stan-dard of procaterol hydrochloride tablets.
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