苏茜
SU Qian (Guangzhou Baiyun Mountain Qiao-guang Pharmaceuticals LTD

• 1:广州白云山侨光制药有限公司 广州510380

摘要(Abstract)：

目的建立复方硫酸沙丁胺醇双层片中硫酸沙丁胺醇、富马酸酮替芬及甘草酸单铵盐的HPLC测定方法。方法采用高效液相色谱法,外标法。色谱条件:采用Luna 5u C18(250×4.6 mm)色谱柱。检测波长为276 nm,考察了方法的线性范围、回收率、精密度、重复性等指标。结果所考察的浓度范围内具有良好线性,硫酸沙丁胺醇、富马酸酮替芬及甘草酸单铵盐的线性范围分别是30~150μg/m l(r=0.9998)、9.15~45.76μg/m l(r=0.9990)、及0.66~3.3 mg/m l(r=0.9999),平均回收率分别为100.1%(RSD为0.12%)、99.98%(RSD为0.46%)、99.59%(RSD为1.01%)(n=9)。结论方法准确简便,重复性好,适用于该制剂的含量测定。
Objective To establish a HPLC method for the content determination of salbutamol-sulfate composite tablet.Methods HPLC analysis was carried out in Luna C_(18)(250×4.6 mm)column with the wavelength of 276 nm .Result The method had a good linear relation in the range of 30～150 μg/ml for salbutamol-sulfate(r=0.9998)、9.15～45.76 μg/ml for ketotifen-fumarate(r=0.9990) and 0.66～3.3 mg/ml for glycyrrhizinate ammonium(r=0.9999),The average recovery rate(n=9) were 100.1% for salbutamol-sulfate(RSD was 0.12%)、99.98% for ketotifen-fumarate(RSD was 0.46%)、99.59% for glycyrrhizinate ammonium(RSD was 1.01%) respectively.Conclusion The proposed method is convenient,accurate and credible for the quality control of salbutamol-sulfate composite tablet.

关键词(KeyWords)： 高效液相色谱法;硫酸沙丁胺醇;富马酸酮替芬;甘草酸单铵盐
HPLC;salbutamol-sulfate;ketotifen-fumarate;ammonium glycyrrhizinate

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 苏茜
SU Qian (Guangzhou Baiyun Mountain Qiao-guang Pharmaceuticals LTD

参考文献(References)：

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