摘要
目的:建立测定氨溴特罗口服溶液中羟乙基纤维素的高效液相色谱-电雾式检测器(HPLC-CAD)方法。方法:采用TSKgtl G2000SW(60 cm×7.5mm,10μm),以10 mmol·L^(-1)乙酸铵(pH 4.5)-乙腈=95∶5为流动相,柱温:30℃,流速:1.0 mL·min^(-1),电雾式检测器的蒸发温度为50℃。结果:该方法对羟乙基纤维素专属性良好,精密度、平行性和回收率均满足分析要求,峰面积线性关系良好(r>0.995)。结论:新建方法专属性好、操作简便,可以满足氨溴特罗口服溶液中羟乙基纤维素分析的要求。
Objective:To establish an high-performance liquid chromatography-electrospray detection(HPLC-CAD)method for the determination of hydroxyethyl cellulose in ambroxol oral solution.Methods:TSK GTL G2000SW column(60 cm×7.5 mm,10μm)was used as a mobile phase with 10 mmol·L^(-1) ammonium acetate(pH 4.5):acetonitrile=95∶5,column temperature:30℃,flow rate:1.0 mL·min^(-1).The evaporating temperature of the electrospray detector was 50℃.Results:The method has good specificity for hydroxyethyl cellulose,and the precision,parallelism and recovery meet the analysis requirements.The linear relationship of peak area was good(r>0.995).Conclusion:The new method has the advantages of good specificity and simple operation,and can meet the requirements of the analysis of hydroxyethyl cellulose in ambroxol oral solution.
作者
郑秋灵
包瑶萍
李燕贤
陈新国
熊亮
ZHENG Qiuling;BAO Yaoping;LI Yanxian;CHEN Xinguo;XIONG Liang(Guangdong Guobiao Pharma-Tech Co.,Ltd,Guangzhou 510000,China;Sommerfisher Technology China Co.,Ltd.,Shanghai 200237,China)
出处
《中国药品标准》
CAS
2023年第1期104-108,共5页
Drug Standards of China
关键词
电雾式检测器
药用辅料
羟乙基纤维素
高效液相色谱法
charged aerosol detector
pharmaceutical excipients
hydroxyethyl cellulose
high-performance liquid chromatography
