反相高效液相色谱法测定盐酸氨溴索注射液的含量 [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( mm×150 mm,5 μm);流动相: mol/L磷酸氢二铵溶液()-乙腈(48∶52);柱温:室温;流速: mL/min;检测波长:248 nm;进样体积:20 μL。 04~ 00 μg(r = ,n = 5);盐酸氨溴索注射液的高、中、%(RSD = %,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 [中图分类号] [文献标识码] A [文章编号] 1673-7210(2014)01(b)-0111-03 Determination of Ambroxol Hydrochloride Injection by RP-HPLC 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 C18 column ( mm×150 mm, 5 μm) with the mobile phase consisted of mol/L diammonium phosphate solution (adjusted to pH with phosphoric acid)-acetonitrile (48 ∶52) at ambient temperature. The flow rate was mL/min. The detective wavelength was 248 nm. The injection volume was 20 μL. Results The liner range of Ambroxol Hydrochloride was 04- 00 μg (r = , n = 5). The average recovery was % (RSD = %, 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