盐酸氨溴索注射液有关物质检查方法研究

摘要

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.%目的：建立高效液相色谱法测定盐酸氨溴索注射液有关物质。方法采用 Diamonsil C18色谱柱（250 mm ×4．5 mm，5μm），以0．01 mol／L 磷酸氢二铵溶液（用磷酸调节 pH 至4．0）－甲醇（45∶55）为流动相，流速为1．0 ml／min，检测波长为250 nm 和238 nm。结果盐酸氨溴索杂质 B 在3．6～23．9 ng／ml 范围内浓度与峰面积呈良好的线性关系，r ＝0．9987，平均回收率为103．3％～109．4％，RSD ＝3．8％；盐酸氨溴索杂质 E 在1．74 ng／ml ～14．64 ng／ml 范围内浓度与峰面积呈良好的线性关系，r ＝0．9996，平均回收率为96．4％～104．8％，RSD ＝3．9％。结论试验结果表明本方法简便、快速、准确，适用于盐酸氨溴索注射液试验样品与参比样品有关物质检查。