HPLC法测定盐酸溴己新注射液含量及有关物质  

Determination of bromhexine hydrochloride injection and its related substances by HPLC

作　　者：孙莉[1] 

机构地区：[1]安徽省芜湖市药品检验所,安徽芜湖241001

出　　处：《安徽医药》2008年第2期121-122,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立HPLC法测定盐酸溴己新注射液含量及有关物质。方法用Phenomenex C18柱（150mm×4．6mm，5μm），以1％醋酸水溶液-甲醇（40：60）为流动相，流速为1.0 ml·min^-1，检测波长为250nm。结果盐酸溴己新线性范围为20.13-201.30mg·L^-1（r=0.9998）；平均回收率为100.4％，RSD为0.48％。结论该方法灵敏，快速，结果准确，可用于盐酸溴己新注射液的质量控制。Aim To establish a method for determination of bromhexine hydrochloride injection and its related substances. Method The column was Phenomenex C18 column（ 150 mm×4.6 mm, 5μm）. The mobile phase was 1% acetic acid-methanol（40：60）, The flow-rate was 1.0 ml·min^-1, and the detection wave length was 205 nm, Results The calibration curves of bromhexine hydrochloride ranged from 20.13 to 201.30 mg·L^-1（ r=0.9998）, The average recovery rate was 100.4% and RSD was 0.48%, Conclusion The method is sensitive, accurate and rapid, It can be used to determine the content of bromhexine hydrochloride injection and its related substances.

关 键 词：HPLC 盐酸溴己新注射液 含量 有关物质 

分 类 号：R927[医药卫生—药学]