高效液相色谱法测定氨溴特罗口服溶液中的杂质5-羟甲基糠醛  

Determination of impurity 5-hydroxymethyl furfural in Ambroxol and Clenbuterol Hydrochloride Oral Solution by high-performance liquid chromatography

作　　者：朱明儒 张靖 ZHU Mingru;ZHANG Jing(Jilin Provincial Institute for Drug Control,Jilin Province,Changchun130033,China)

机构地区：[1]吉林省药品检验研究院,吉林长春130033

出　　处：《中国当代医药》2024年第32期19-23,共5页China Modern Medicine

摘　　要：目的建立氨溴特罗口服溶液中杂质5-羟甲基糠醛的定量分析方法,并对其进行方法学研究以考察该方法的可行性与准确性。方法采用高效液相色谱法对7家生产企业的产品进行检验,同时利用外标法测定其中5-羟甲基糠醛的含量。结果经方法学验证表明,5-羟甲基糠醛峰和相邻色谱峰之间的分离度良好,定量限为0.38 ng,检测限为0.11 ng,在0.0379~1.8960μg/ml范围内呈良好线性关系(r=1.0000),平均回收率为100.6%,RSD为0.35%(n=6)。结论该方法可用于氨溴特罗口服溶液中杂质5-羟甲基糠醛的定量测定。Objective To establish a quantitative analysis method for the determination of impurity 5-hydroxymethyl furfural in Ambroxol and Clenbuterol Hydrochloride Oral Solution,and conduct methodological research to investigate the feasibility and accuracy of this method.Methods The high-performance liquid chromatography was used to test the products of seven manufacturers and the content of 5-hydroxymethyl furfural was determined by external standard method.Results The results showed that the separation between 5-hydroxymethyl furfural and the adjacent chromatographic peaks was satisfactory,the quantification limit and detection limit of 5-hydroxymethyl furfural were 0.38 ng and 0.11 ng,the linear relationship was good in the range of 0.0379-1.8960μg/ml(r=1.0000),the average recovery was 100.6%and RSD was 0.35%(n=6).Conclusion The method can be used for the quantitative determination of 5-hydroxymethyl furfural in Ambroxol and Clenbuterol Hydrochloride Oral Solution.

关 键 词：氨溴特罗口服溶液 5-羟甲基糠醛 杂质控制 高效液相色谱法 

分 类 号：R927[医药卫生—药学]