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.
出处
《中国药业》
CAS
2017年第16期18-23,共6页
China Pharmaceuticals
作者简介
柴洪帆，女，硕士研究生，中级工程师，研究方向为药品质量控制，（电子信箱）wangyl580@163．com。
