愈创木酚甘油醚和右美沙芬复方制剂中杂质同时测定的方法研究  

Simultaneous Determination of Impurities in Guaifenesin and Dextromethorphan Compound Preparation

作　　者：柴洪帆[1] 郑扬[1] 曹霞[1] 

机构地区：[1]海南澳美华制药有限公司,海南海口570311

出　　处：《中国药业》2017年第16期18-23,共6页China Pharmaceuticals

摘　　要：目的建立可同时检测愈创木酚甘油醚和右美沙芬复方制剂中有关物质的方法。方法色谱柱为Waters XBridge C_(18)柱(250 mm×4.6 mm,3.5μm),流动相A为pH=3.0的磷酸二氢钾溶液-乙腈(90∶10,V/V),流动相B为pH=2.8的磷酸二氢钾溶液-乙腈-甲醇(10∶10∶80,V/V/V),梯度洗脱,检测波长为280 nm。结果强制降解条件(氧化、酸、碱、高温、光照)下,主成分与杂质均得到了有效检测。愈创木酚甘油醚、右美沙芬和其他8种特定杂质质量浓度在线性范围内与峰面积线性关系良好。结论所建立的方法准确度、检测限、定量限、精密度、耐用性等均符合人用药品注册技术要求国际协调会议(ICH)指导原则的要求。Objective To establish a method for simultaneous determination of guaifenesin and dextromethorphan compound preparation.Methods The chromatographic column was Waters XBridge C_（18） 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 Under the conditions of forced degradation（ oxidation,acid,alkali,high temperature,light）,the principal components and impurities were effectively detected. Guaifenesin,dextromethorphan and other 8 kinds of specific impurities had a good linear relationship in the concentration 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 

分 类 号：R927[医药卫生—药学]