高效液相色谱法测定盐酸溴己新片的含量

Content analysis of bromhexine hydrochloride in tablets by HPLC

目的建立高效液相色谱法测定盐酸溴己新片的含量。方法色谱柱：Alhima C18柱（4．6mm×150mm，5μm）；流动相：乙腈-0．05mol·L^-1磷酸盐缓冲液（含0．2％三乙胺，pH=3．0）（体积比30：70），流速1．0mL·min^-1，检测波长为249nm。结果盐酸溴己新在66．0～96．4μg·mL。浓度范围内线性良好（r=0．9999，n=5），平均回收率为98．85％（RSD=0．60％，n=6）。结论本法快速、简便、准确，重复性好。

Objective To establish a method for content determination of bromhexine hydrochloride in tablets. Methods Bromhexine hydrochloride in the tablets was analyzed on an Alhima C18 （4. 6 mm × 150 mm, 5μm ） column with mobile phase composed of acetonitrile-0.05 mol · L^-1 phosphate buffer （30： 70, final pH3.0 adjusted with 0.2% triethylamine）. The flow rate was 1.0 mL · min^ -1 with UV detection wavelength at 249 nm. Results Calibration graph was linear （ r = 0. 9999, n = 6 ） in concentration range 66.0- 96.4 μg · mL^-1 The average recovery of bromhexine hydrochloride was 98.85% and RSD 0. 60% （ n = 6 ）, Conclusions The method is simple, rapid and reproducible.