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反相高效液相色谱法测定盐酸氨溴索注射液的含量
引用本文:刘淑华.反相高效液相色谱法测定盐酸氨溴索注射液的含量[J].中国医药导报,2014(2):111-113.
作者姓名:刘淑华
作者单位:辽宁省朝阳市食品药品检验所,辽宁朝阳122000
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.

关 键 词:反相高效液相色谱法  盐酸氨溴索注射液  含量测定

Determination of Ambroxol Hydrochloride Injection by RP-HPLC
LIU Shuhua.Determination of Ambroxol Hydrochloride Injection by RP-HPLC[J].China Medical Herald,2014(2):111-113.
Authors:LIU Shuhua
Institution:LIU Shuhua (Institute for Food and Drug Control of Chaoyang City in Liaoning Province, Chaoyang 122000, China)
Abstract: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.
Keywords:RP-HPLC  Ambroxol Hydrochloride Injection  Content determination
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