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HPLC法测定盐酸溴己新注射液含量及有关物质
引用本文:孙莉. HPLC法测定盐酸溴己新注射液含量及有关物质[J]. 安徽医药, 2008, 12(2): 121-122
作者姓名:孙莉
作者单位:安徽省芜湖市药品检验所,安徽,芜湖241001
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。

关 键 词:HPLC  盐酸溴己新注射液  含量  有关物质
收稿时间:2007-11-20
修稿时间:2007-11-20

Determination of bromhexine hydrochloride injection and its related substances by HPLC
SUN Li. Determination of bromhexine hydrochloride injection and its related substances by HPLC[J]. Anhui Medical and Pharmaceutical Journal, 2008, 12(2): 121-122
Authors:SUN Li
Affiliation:SUN Li ( Wuhu Institute for Drug Control,Wuhu,Anhui Province 241001 )
Abstract:
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.
Keywords:HPLC   bromhexine hydrochloride injection   content  related substances
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