反相离子对高效液相色谱法测定盐酸溴己新及其片剂的含量  

Determination of Bromhexine Hydrochloride and Its Tablets by RP-IP-HPLC

作　　者：郑凯 王玉红 杨阔[2] 

机构地区：[1]辽宁省朝阳市药品检验所,辽宁朝阳122000 [2]中国药科大学,江苏南京212000

出　　处：《中国药业》2010年第8期32-33,共2页China Pharmaceuticals

摘　　要：目的用反相离子对高效液相色谱(RP-IP-HPLC)法测定盐酸溴己新及其片剂的含量。方法色谱柱为KromasilC18柱(200mm×4.6mm,5μm),流动相为水-甲醇-三乙胺(含5mmol庚烷磺酸钠,用磷酸调pH至3.4,30:70:0.3),检测波长为249nm,流速为0.8mL/min。结果盐酸溴己新进样量在0.0804～1.608μg范围内与峰面积线性关系良好,平均加样回收率为98.25%,RSD=0.72%(n=6)。结论该法简便、结果可靠、专属性强,可用于盐酸溴己新及其片剂的质量控制。Objective To establish a RP- IP- HPLC method for the content determination of bromhexine hydrochloride and its tablets. Methods The Kromasil C18 column（200 mm ×4.6 mm, 5 μm） was used with water- methanol- triethylamine（containing 5 mmol sodium heptanesulfonate,adjusting to pH = 3.4 with phosphoric acid,30 ： 70 ： 0.3） as the mobile phase. The detective wavelength was 249 nm. The flow rate was 0.8 mL/min. Results The linear range was 0. 080 4 - 1. 608 μg（ r = 0. 999 9, n = 6）. The average recovery rate was 98. 25% and RSD=0.72% （n=6）. Conclusion This method is simple,reliable and specific. It can be used in the quality control of bromhexine hydrochloride and its tablets.

关 键 词：反相离子对高效液相色谱法 盐酸溴己新 含量测定 

分 类 号：R927.2[医药卫生—药学] R974.1