摘要
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.
出处
《中国医药导报》
CAS
2014年第2期111-113,共3页
China Medical Herald