复方小儿退热栓中对乙酰氨基酚含量测定及其均匀度研究  

Determination of Content and Content Uniformity of Paracetamol in Compound Child Antifebrile Suppository

作　　者：谢思敏[1] 陈家仪[1] 顾利红[1] 栗建明[1] XIE Simin;CHEN Jiayi;GU Lihong;LI Jianming(Guangzhou Institute for Drug Control·Key Laboratory of Quality Evaluation of Chinese Patent Medicines,NMPA,Guangzhou,Guangdong,China 510166)

机构地区：[1]广东省广州市药品检验所·国家药品监督管理局中成药质量评价重点实验室,广东广州510160

出　　处：《中国药业》2021年第8期49-51,共3页China Pharmaceuticals

基　　金：国家药典委员会药品标准制修订研究课题[2019Z028]。

摘　　要：目的建立测定复方小儿退热栓中对乙酰氨基酚含量的高效液相色谱法,并研究其均匀度。方法色谱柱采用Agilent Zorbax SB-C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(20∶80,V/V),流速1.0 m L/min,检测波长244 nm,柱温30℃,进样量10μL。结果对乙酰氨基酚进样量在0.0819~1.639μg范围内与峰面积线性关系良好(r=0.999 5);精密度、稳定性、重复性试验结果的RSD均小于1.0%;平均加样回收率为101.25%,RSD为0.87%(n=9);17批样品的平均含量为99.35%~107.37%,含量均匀度(A+2.2 S)为2.92~9.38。结论该方法简便准确,重复性好,专属性强,可用于复方小儿退热栓的质量控制。Objective To establish a high-performance liquid chromatography(HPLC)method for the determination of content and content uniformity of paracetamol in Compound Child Antifebrile Suppository.Methods The chromatographic column was Agilent Zorbax SB-C18 column(250 mm×4.6 mm,5μm),the mobile phase was methanol-water(20∶80,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 244 nm,the column temperature was 30℃and the injection volume was 10μL.Results Paracetamol showed good linear relationship with peak area in the range of 0.0819-1.639μg(r=0.9995),the RSDs of precision,stability and repeatability tests were less than 1.0%,the average recovery of paracetamol was 101.25%with RSD of 0.87%(n=9).The contents of 17 batches of samples were in the range of 99.35%-107.37%,and the content uniformity(A+2.2 S)was in the range of 2.92-9.38.Conclusion The method is simple,accurate,reproducible and specific,which can be used for the quality control of Compound Child Antifebrile Suppository.

关 键 词：复方小儿退热栓 高效液相色谱法 对乙酰氨基酚 含量 含量均匀度 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]