文章摘要
郑秋灵,陈新国,包瑶萍,李燕贤,熊亮.高效液相色谱-电雾式检测器测定氨溴特罗口服液中羟乙基纤维素含量[J].中国药品标准,2023,24(1):
高效液相色谱-电雾式检测器测定氨溴特罗口服液中羟乙基纤维素含量
Determination of Hydroxyethyl Cellulose in Ambroxol Hydrochloride and clenbuterol hydrochloride oral solution by high-performance Liquid chromatography-charged aerosol detector (HPLC-CAD)
投稿时间:2022-09-01  修订日期:2023-01-31
DOI:
中文关键词: 电雾式雾式检测器  药用辅料  羟乙基纤维素  高效液相色谱法
英文关键词: Charged aerosol detector (CAD)  Pharmaceutical excipients  Hydroxyethyl Cellulose  HPLC
基金项目:
作者单位E-mail
郑秋灵 广东国标医药科技有限公司 290701923@qq.com 
陈新国* 广东国标医药科技有限公司 315899568@qq.com 
包瑶萍 广东国标医药科技有限公司  
李燕贤 广东国标医药科技有限公司  
熊亮 赛默飞世尔科技中国有限公司  
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中文摘要:
      目的:建立测定氨溴特罗口服液中羟乙基纤维素的高效液相色谱-电雾式雾式检测器(HPLC-CAD)方法。方法:采用TSKgtl G2000SW (60cm×7.5mm,10 μm),以10 mmol/L乙酸铵(pH4.5):乙腈=95:5为流动相,柱温:30 ℃,流速:1.0 mL/min,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液中羟乙基纤维素分析的要求。
英文摘要:
      Objective:To establish a high-performance Liquid chromatography-charged aerosol detector (HPLC-CAD) method for the determination of Hydroxyethyl Cellulose in Ambroxol Hydrochloride and clenbuterol hydrochloride oral solution. Method: the chromatographic column was TSKgtl G2000SW column (60cm×7.5 mm, 10 μm). The mobile phase was 10 mmol/L ammonium acetate (pH4.5)/acetonitrile (95:5, V/V). The flow rate was 1.0 mL/min, and the column temperature was 30℃. The evaporator temperature of CAD was 50℃. Result:This method can separate Hydroxyethyl Cellulose well and has good specificity. The precision, repeatability, and recovery of this method can meet the analysis requirements. There was a good Linearity among the Hydroxyethyl Cellulose (r>0.995). Conclusion:The established method has good specificity and of high maneuverability, which can be used for quantitative analysis of Hydroxyethyl Cellulose analysis in Ambroxol Hydrochloride and clenbuterol hydrochloride oral solution.
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