摘要
建立HPLC法测定盐酸溴己新及其片剂的含量。采用Kromasil C18色谱柱,以甲醇-0.1%磷酸(70∶30)(用三乙胺调pH至3.5)为流动相,柱温为室温,流速为0.8mL·min^-1,检测波长248nm,进样体积为20μL。盐酸溴己新浓度在4.032-40.32μg·mL^-1范围内与相应峰面积呈良好的线性关系,r=0.9999(n=5);高、中、低3种浓度的平均加样回收率为98.1%(RSD=0.76%,n=9)。方法快速、准确、专属性强。
A method for the determination of bromhexine hydrochloride and its tablets by HPLC was establish.The determination was performed on a Kromasil C18column with the mobile phase consisting of methanol-0.1%phosphoric acid solution(70∶30)(pH was adjusted to 3.5 with triethylamine)at ambient temperature.The flow rate was 0.8mL·min^-1.The detection wavelength was 248nm.The injection volume was 20μL.The method showed a good linear relationship within the range of 4.032-40.32μg.mL-1(r=0.9999,n= 5).The average recovery was 98.1% for the three different levels of the added amount of bromhexine hydrochloride with RSD = 0.76%(n = 9).This method is rapid,specific and accurate.
出处
《中国药事》
CAS
2008年第1期68-69,79,共3页
Chinese Pharmaceutical Affairs