摘要
Abstract
Objective To establish a method for determining the related substance content in Ambroxol Hydrochloride Injection. Methods The HPLC method was adopted for conducting the dual wavelength determination of the content of the related substances in Ambroxol Hydrochloride Injection. The XB-C18 column ( Agilent Zorbax 250 mm × 4. 6mm, 5 μm ) was adopted with 0. 01 mol/L diammonium phosphate solution ( adjusting pH to 7. 0 with phosphoric acid ) -acetonitrile ( 42 :58 ) as the mobile phase, the detection wavelength of 250 nm ( testing ambroxol hydrochloride, impurities B and other impurities ) and 238 nm ( testing impurity E ) as the mobile phase; the column temperature was 40℃;the flow rate was 1. 0 mL/min;the sample size was 20 μL. Results The impurity A sample size in the range of 0. 020-20. 02μg had good linear relationship ( r=0. 999 9 );the impurity B sample size in the range of 0. 602-20. 08μg had good linear relationship( r=0. 999 6), the average recovery rate was 99. 6%( n=6);the impurity D sample size in the range of 0. 060 7-20. 22μg had good linear relationship ( r=0. 999 1 );the impurity E sample size in the range of 0. 061-20. 16μg had good linear re-lationship ( r=0. 999 3 ) , the average recovery rate was 99. 8% ( n=6 );the ambroxol hydrochloride ( 250 nm, 238 nm ) sample size in the range of 0. 060-20. 16μg had good linear relationship ( r=0. 999 7, r=0. 999 5 ) . Conclusion This method is accurate and reliable in quantitation, simple and convenient to operate, highly sensitive and suitable for the quality control of related substances in Ambroxol Hy-drochloride Injection.关键词
有关物质/高效液相色谱法/双波长Key words
related substance/HPLC/double wavelength分类
医药卫生
