摘要
该研究旨在搭建HPLC方法检测复方氨酚溴敏胶囊中对氨基酚的含量。采用C_(8)柱(4.6 mm×250 mm,5μm),A相为100 mmol/L高氯酸钠(含0.1%高氯酸),B相为乙腈,1.0 mL/min流速,230 nm波长,20μL进样量,进行梯度洗脱。结果显示对氨基酚浓度在0.994~99.4μg/mL(r^(2)=0.999)范围线性关系良好,平均回收率为101.2%,重复性和精密度试验RSD均为0.3%,专属性试验结果良好。研究表明该方法可用于复方氨酚溴敏胶囊中对氨基酚的检查,高效易行,为复方氨酚溴敏胶囊质量控制的研究提供参考。
Aiming to construct the HPLC method to detect the content of paraminophen in compound capsules,gradient elution was performed with a C _(8 )column(4.6 mm×250 mm,5μm),100 mmol/L sodium perchlorate(containing 0.1%perchloric acid)in phase A,phase B,acetonitrile,1.0 mL/min flow rate,230 nm wavelength,20μL injection.The results showed a good linear relationship between parataminophen concentration in the range of 0.994~99.4μg/mL(r ^(2)=0.999),with an average recovery of 101.2%,both repeatability and precision test RSD of 0.3%,and good specificity test results.The result showed that this method could be used for the examination of paraminophen in compound capsules,highly efficient and easy to perform,and provided a reference for the study of quality control of compound aminophen bromamine capsules.
作者
曾金亮
周雅丽
庞发根
梁智渊
刘敏
殷果
李玉兰
王晓炜
ZENG Jin-liang;ZHOU Ya-li;PANG Fa-gen;LIANG Zhi-yuan;LIU Min;YIN Guo;LI Yu-lan;WANG Xiao-wei(Shenzhen Institute for Drug Control,Guangdong Shenzhen 518057,China)
出处
《广州化工》
CAS
2023年第11期122-125,共4页
GuangZhou Chemical Industry
关键词
对氨基酚
HPLC法
有关物质
para-aminophenol l
HPLC method
related substances