反相高效液相色谱法测定盐酸氨溴索注射液的含量

Determination of Ambroxol Hydrochloride Injection by RP-HPLC

目的 建立反相高效液相色谱法测定盐酸氨溴索注射液含量的方法.方法 色谱柱：Kromasil C18（4.6 mm×150 mm,5μm）;流动相：0.005 mol/L磷酸氢二铵溶液（磷酸调节pH值至7.0）-乙腈（48∶52）;柱温：室温;流速：1.0 mL/min;检测波长：248 nm;进样体积：20 μL.结果 盐酸氨溴索的线性范围为0.060 04～1.501 00 μg（r=0.9999,n=5）;盐酸氨溴索注射液的高、中、低3种浓度的平均加样回收率为99.4％（RSD=0.6％,n=9）.结论 该方法专属性强、准确、重现性好,可用于盐酸氨溴索注射液含量的测定.

Objective To establish a method for the determination of Ambroxol Hydrochloride Injection by RP-HPLC.Methods The determination was performed on a Kromasil C1s column （4.6 mm×150 mm,5 μm） with the mobile phase consisted of 0.005 mol/L diammonium phosphate solution （adjusted to pH 7.0 with phosphoric acid）-acetonitrile （48：52） at ambient temperature.The flow rate was 1.0 mL/min.The detective wavelength was 248 nm.The injection volume was 20 μL.Results The liner range of Ambroxol Hydrochloride was 0.060 04-1.501 00 μg （r =0.9999,n =5）.The average recovery was 99.4% （RSD =0.6%,n =9） for the three different levels of the added amount of Ambroxol Hydrochloride.Conclusion This method is specific,accurate and reproducible.It can be used for determination of Ambroxol Hydrochloride Injection.