摘要
Abstract
Objective To establish a method for simultaneous determination of guaifenesin and dextromethorphan compound preparation. Methods The chromatographic column was Waters XBridge C18 column(250 mm × 4. 6 mm,3. 5μm). The mobile phase A consisted of pH=3. 0 monopotassium phosphate solution-acetonitrile (90 : 10,V/ V),the mobile phase B consisted of pH=3. 0 monopotassium phosphate solution-acetonitrile-methanol(10 :10 :80,V/ V/ V),gradient elution,the detection wavelength was 280 nm. Results Un-der the conditions of forced degradation(oxidation,acid,alkali,high temperature,light),the principal components and impurities were ef-fectively detected. Guaifenesin,dextromethorphan and other 8 kinds of specific impurities had a good linear relationship in the concentra-tion range. Conclusion The established method is validated according to ICH guidelines with respect to accuracy,limits of inspection, limits of quantification,precision and durability.关键词
反相高效液相色谱法/愈创木酚甘油醚/右美沙芬/复方制剂/杂质Key words
RP-HPLC/guaifenesin/dextromethorphan/compound preparation/impurity分类
医药卫生
