Analysis of related substances in ambroxol hydrochloride injection
Shen An
Fan Qingyi
Zhao Yuqing
Wang Yanmin
Gu Guoling
Abstract：Objective To establish an HPLC method to analysis the related substances in ambroxol hydrochioride injection. Methods The column was Diamonsil C18 chromatographic column (250 mm ×4.5 mm,5μm),the mobile phase consisted of 0.01 mol/L diammonium hydrogen phosphate solution (adjust to pH 4.0 with phosphoric acid) -methanol (45∶55)with a flow rate of 1.0 ml/min,the UV detection wavelength was set at 250 nm and 238 nm.Results The impurity B had good linear rela-tionship with the peak area over the range of 3.6 -23.9 ng/ml,r =0.998 7,the average recovery was 103.3% ~109.4%,RSD =3.8%;the impurity E had good linear relationship with the peak area over the range of 1.74 ~14.64 ng/ml,r =0.999 6,and the average recovery was 96.4% -104.8%,RSD =3.9%.Conclusion The method is simple,rapid and accurate,and it can be used in analyzing the related substances in ambroxol hydrochioride injection.
Keywords：ambroxol hydrochioride injectionHPLCrelated substances
Publication Date：2015-01-01
Online Publishing Date：2026-09-12(First online date of this platform, not the publication date of the document)
Pages：5( 30-34 )